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StecoGuide

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref M.27.03.D150Ref M.27.06.D220Ref M.27.03.D235Ref M.27.02.D350Ref M.27.06.D340Ref M.27.06.D160Ref M.27.06.D320Ref M.27.03.D225L6Ref M.27.02.D350L5Ref M.27.06.D350Ref M.27.03.D235L6Ref M.27.01.D235Ref M.27.03.D200L6Ref M.27.01.D225L5Ref M.27.06.D200Ref M.27.01.D116L4Ref M.27.06.D300Ref M.27.01.D200L5Ref M.27.01.D210L4Ref M.27.06.D280Ref M.27.01.D166L4Ref M.27.03.D250L6Ref M.27.03.D160L6Ref M.27.06.D240Ref M.27.07.D521L4Ref M.27.03.D200Ref M.27.03.D280L6Ref M.27.01.D220L4Ref M.27.06.D235Ref M.27.01.D126L4Ref M.27.06.D330

by steco-System-Technik GmbH & Co KG

Identity

Trade Name
StecoGuide EUDAMEDFDA UDI
Generic Name
Surgical drill guide, single-use FDA UDI
Device Name
Planning and drill sleeves EUDAMED
Titanium inner sleeve D3.5/d2.35/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.5/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium single sleeve for implant planning and CT analysis D3.0/d2.35/L10.0-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.0/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.8/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.3/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d1.6/L5.0 -> For further information visit steco.de FDA UDI
Titanium single sleeve D3.0/d2.02/L5.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.2/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.0/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d1.6/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve for template guided implant surgery D3.5/d2.25/L6.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.4/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.35/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.2/L5.0 -> For further information visit steco.de FDA UDI
Titanium outer sleeve D4.0/d3.5/L5.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.8/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d1.5/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.4/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.0/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium outer sleeve D4.0/d3.5/L6.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.0/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.5/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.35/L5.0 -> For further information visit steco.de FDA UDI
Model / Reference
M.27.03.D235 EUDAMEDFDA UDI
M.27.03.D250L6 EUDAMEDFDA UDI
M.27.01.D235 EUDAMEDFDA UDI
M.27.06.D200 EUDAMEDFDA UDI
M.27.03.D280L6 EUDAMEDFDA UDI
M.27.06.D330 EUDAMEDFDA UDI
M.27.06.D160 EUDAMEDFDA UDI
M.27.01.D200L5 EUDAMEDFDA UDI
M.27.06.D220 EUDAMEDFDA UDI
M.27.03.D200 EUDAMEDFDA UDI
M.27.03.D160L6 EUDAMEDFDA UDI
M.27.03.D225L6 EUDAMEDFDA UDI
M.27.06.D340 EUDAMEDFDA UDI
M.27.03.D235L6 EUDAMEDFDA UDI
M.27.06.D320 EUDAMEDFDA UDI
M.27.02.D350L5 EUDAMEDFDA UDI
M.27.06.D280 EUDAMEDFDA UDI
M.27.03.D150 EUDAMEDFDA UDI
M.27.06.D240 EUDAMEDFDA UDI
M.27.03.D200L6 EUDAMEDFDA UDI
M.27.02.D350 EUDAMEDFDA UDI
M.27.06.D300 EUDAMEDFDA UDI
M.27.06.D350 EUDAMEDFDA UDI
M.27.06.D235 EUDAMEDFDA UDI
M.27.01.D225L5 EUDAMED
M.27.01.D116L4 EUDAMED
M.27.01.D210L4 EUDAMED
M.27.01.D166L4 EUDAMED
M.27.07.D521L4 EUDAMED
M.27.01.D220L4 EUDAMED
M.27.01.D126L4 EUDAMED
Description
Titanium inner sleeve D3.5/d2.35/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.5/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium single sleeve for implant planning and CT analysis D3.0/d2.35/L10.0-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.0/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.8/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.3/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d1.6/L5.0 -> For further information visit steco.de FDA UDI
Titanium single sleeve D3.0/d2.02/L5.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.2/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.0/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d1.6/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium inner sleeve for template guided implant surgery D3.5/d2.25/L6.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.4/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.35/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.2/L5.0 -> For further information visit steco.de FDA UDI
Titanium outer sleeve D4.0/d3.5/L5.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.8/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d1.5/L10.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.4/L5.0 -> For further information visit steco.de FDA UDI
Titanium inner sleeve D3.5/d2.0/L6.0 for implant planning and CT analysis -> For further information visit steco.de FDA UDI
Titanium outer sleeve D4.0/d3.5/L6.0 for surgical guides/templates-> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.0/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d3.5/L5.0 -> For further information visit steco.de FDA UDI
CeHa drill sleeve [inner] for template guided implant surgery D4.5/d2.35/L5.0 -> For further information visit steco.de FDA UDI

Identifiers

Catalog Number
M.27.03.D235 FDA UDI
M.27.03.D250L6 FDA UDI
M.27.01.D235 FDA UDI
M.27.06.D200 FDA UDI
M.27.03.D280L6 FDA UDI
M.27.06.D330 FDA UDI
M.27.06.D160 FDA UDI
M.27.01.D200L5 FDA UDI
M.27.06.D220 FDA UDI
M.27.03.D200 FDA UDI
M.27.03.D160L6 FDA UDI
M.27.03.D225L6 FDA UDI
M.27.06.D340 FDA UDI
M.27.03.D235L6 FDA UDI
M.27.06.D320 FDA UDI
M.27.02.D350L5 FDA UDI
M.27.06.D280 FDA UDI
M.27.03.D150 FDA UDI
M.27.06.D240 FDA UDI
M.27.03.D200L6 FDA UDI
M.27.02.D350 FDA UDI
M.27.06.D300 FDA UDI
M.27.06.D350 FDA UDI
M.27.06.D235 FDA UDI
Primary DI / UDI-DI
+ESTOM2703D150 EUDAMED
+ESTOM2706D220 EUDAMED
+ESTOM2703D235 EUDAMED
+ESTOM2702D350 EUDAMED
+ESTOM2706D340 EUDAMED
+ESTOM2706D160 EUDAMED
+ESTOM2706D320 EUDAMED
+ESTOM2703D225L6 EUDAMED
+ESTOM2702D350L5 EUDAMED
+ESTOM2706D350 EUDAMED
+ESTOM2703D235L6 EUDAMED
+ESTOM2701D235 EUDAMED
+ESTOM2703D200L6 EUDAMED
+ESTOM2701D225L5 EUDAMED
+ESTOM2706D200 EUDAMED
+ESTOM2701D116L4 EUDAMED
+ESTOM2706D300 EUDAMED
+ESTOM2701D200L5 EUDAMED
+ESTOM2701D210L4 EUDAMED
+ESTOM2706D280 EUDAMED
+ESTOM2701D166L4 EUDAMED
+ESTOM2703D250L6 EUDAMED
+ESTOM2703D160L6 EUDAMED
+ESTOM2706D240 EUDAMED
+ESTOM2707D521L4 EUDAMED
+ESTOM2703D200 EUDAMED
+ESTOM2703D280L6 EUDAMED
+ESTOM2701D220L4 EUDAMED
+ESTOM2706D235 EUDAMED
+ESTOM2701D126L4 EUDAMED
+ESTOM2706D330 EUDAMED
ESTOM2703D2350 FDA UDI
ESTOM2703D250L60 FDA UDI
ESTOM2701D2350 FDA UDI
ESTOM2706D2000 FDA UDI
ESTOM2703D280L60 FDA UDI
ESTOM2706D3300 FDA UDI
ESTOM2706D1600 FDA UDI
ESTOM2701D200L50 FDA UDI
ESTOM2706D2200 FDA UDI
ESTOM2703D2000 FDA UDI
ESTOM2703D160L60 FDA UDI
ESTOM2703D225L60 FDA UDI
ESTOM2706D3400 FDA UDI
ESTOM2703D235L60 FDA UDI
ESTOM2706D3200 FDA UDI
ESTOM2702D350L50 FDA UDI
ESTOM2706D2800 FDA UDI
ESTOM2703D1500 FDA UDI
ESTOM2706D2400 FDA UDI
ESTOM2703D200L60 FDA UDI
ESTOM2702D3500 FDA UDI
ESTOM2706D3000 FDA UDI
ESTOM2706D3500 FDA UDI
ESTOM2706D2350 FDA UDI
Basic UDI-DI
++ESTOM27LB EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Surgical drill guide, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.3980 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDIFDA UDI

Category: Surgical drill guide, single-use

StecoGuide by steco-System-Technik GmbH & Co KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
steco-System-Technik GmbH & Co KG

Sources (55)

  • FDA UDI 2001bf61-1713-4044-90d6-779eb7b9877c 35 fields · synced Sep 18, 2026
  • FDA UDI ed6acb08-3aab-44de-89c6-732ee32ceb38 35 fields · synced May 24, 2026
  • FDA UDI 5d0cfc8e-bccc-4d14-9719-a570fc9b6ecc 35 fields · synced May 24, 2026
  • FDA UDI cf6393bf-91c1-431a-8f9e-43b9d321c342 35 fields · synced May 24, 2026
  • FDA UDI 2844bd7d-3fed-40ec-b9c5-626b6a87eb26 35 fields · synced May 25, 2026
  • FDA UDI c5e583d8-7254-4d4c-94dd-0558874c4a57 35 fields · synced May 25, 2026
  • FDA UDI e62f20d5-a9dc-42ee-8d92-9298ac0d3a8b 35 fields · synced May 25, 2026
  • FDA UDI de190903-6ec3-44cd-94c8-fb5999127914 35 fields · synced May 27, 2026
  • FDA UDI f85e3896-f335-4305-bc31-6f0af7f49546 35 fields · synced May 27, 2026
  • FDA UDI 701ed26b-d805-4a37-8ac2-4b44e4233baa 35 fields · synced May 29, 2026
  • FDA UDI 49bd0f09-e403-4752-b65c-5f94c836ac88 35 fields · synced May 30, 2026
  • FDA UDI bca27dda-0995-4e5d-8b01-08ff8c20f64a 35 fields · synced May 30, 2026
  • FDA UDI 29d8e257-a6cf-4d3a-86e1-1e5b7afccc47 35 fields · synced May 30, 2026
  • FDA UDI eecc6679-670f-49c5-8e5d-fb230acdbdac 35 fields · synced May 30, 2026
  • FDA UDI 82c1f211-309d-4308-92c9-63e3256e01a9 35 fields · synced May 30, 2026
  • FDA UDI a6ed6496-426b-4a19-9207-b2ccfdc6d0e9 35 fields · synced May 30, 2026
  • FDA UDI e1e3cf4c-158a-4d1b-b568-91d84f52dd82 35 fields · synced May 30, 2026
  • FDA UDI ed560dd1-e168-4fe9-a22f-06953a7e37a6 35 fields · synced May 30, 2026
  • FDA UDI 13aa8571-0656-4a15-a06b-85a36ca49ffe 35 fields · synced May 30, 2026
  • FDA UDI f41b9679-1712-4ae0-b0f2-75c95e585bb3 35 fields · synced May 30, 2026
  • FDA UDI c7cc0ba5-06c6-4336-9378-86e5bd64ebc5 35 fields · synced May 30, 2026
  • FDA UDI f208e1bd-a2b2-42fc-abf8-33592711edc3 35 fields · synced May 30, 2026
  • FDA UDI 58968573-f889-406e-a658-e8a103ac7b68 35 fields · synced May 30, 2026
  • FDA UDI ad03eaea-ac5a-4885-a8a2-f7a340a4421f 35 fields · synced May 30, 2026
  • EUDAMED fb33e66f-6416-4855-9a04-7792ad1fc263 61 fields · synced Jun 20, 2026
  • EUDAMED 02e27935-432b-449c-9b4e-3fc1a4fcd9fd 61 fields · synced Jul 8, 2026
  • EUDAMED 0e2d8cc6-7de1-4b43-ba06-0d9f6121aa71 61 fields · synced Jul 8, 2026
  • EUDAMED 2c303e33-06a6-4f9c-bec8-3d13f572043a 61 fields · synced Jul 9, 2026
  • EUDAMED 4a15cc35-bc00-4a2d-9ba2-375b41160e7c 61 fields · synced Jul 9, 2026
  • EUDAMED bba34262-536c-4c94-a42a-d310faffc745 61 fields · synced Jul 9, 2026
  • EUDAMED fa3af275-8aec-4dbd-94a2-3cd29fe58c26 61 fields · synced Jul 9, 2026
  • EUDAMED 18e69f2f-0860-4f4d-a993-86ee99101de9 61 fields · synced Jul 10, 2026
  • EUDAMED e3f5444b-56c2-4727-b08b-0f4f3c75ab62 61 fields · synced Jul 10, 2026
  • EUDAMED 86b09454-edae-42f6-b77d-9fee6698275b 61 fields · synced Jul 12, 2026
  • EUDAMED 19a50a94-d089-42f2-a51c-fbd1a3e3ef45 61 fields · synced Jul 13, 2026
  • EUDAMED 4d14bab4-7666-4450-87ca-34f386c19279 61 fields · synced Jul 13, 2026
  • EUDAMED 39170e0f-75b6-456f-a3d9-5fab4305328c 61 fields · synced Jul 13, 2026
  • EUDAMED f371a2bc-89a4-41b9-8422-f9ecf17b23fc 61 fields · synced Jul 13, 2026
  • EUDAMED b04c5f72-0a6d-4521-8012-2636d541790f 61 fields · synced Jul 13, 2026
  • EUDAMED c266d952-b0fd-4632-b10a-f76d24cf49a5 61 fields · synced Jul 14, 2026
  • EUDAMED 700051f7-043e-4d34-8752-1739ee2728bf 61 fields · synced Jul 14, 2026
  • EUDAMED b54c0a6e-df08-40d6-a47f-389140207914 61 fields · synced Jul 15, 2026
  • EUDAMED 17594372-9798-4ccf-a059-d1cd587ff041 61 fields · synced Jul 15, 2026
  • EUDAMED 8e1c8eb6-a390-4780-8748-d92dba09b0df 61 fields · synced Jul 15, 2026
  • EUDAMED b0a54735-64e9-41c4-981d-7527c3adf0dc 61 fields · synced Jul 15, 2026
  • EUDAMED 8969bc19-10cd-488c-a597-fbf7c845dced 61 fields · synced Jul 18, 2026
  • EUDAMED d349288b-1a23-4346-bc60-4d8bb5d42fe2 61 fields · synced Jul 19, 2026
  • EUDAMED 29cc7615-3b1c-4cb5-8c32-29e5fdba0d17 61 fields · synced Jul 19, 2026
  • EUDAMED 1f5676ef-2b7d-4607-8224-650d3787754b 61 fields · synced Jul 20, 2026
  • EUDAMED 5c4527e4-d159-4686-9b43-dcce63a1e634 61 fields · synced Jul 21, 2026
  • EUDAMED 5eabdfef-1fd2-476a-8ed8-db93679b6fa1 61 fields · synced Jul 26, 2026
  • EUDAMED 11a1c1d3-d3d9-4ff3-9d60-f78e256ebbec 61 fields · synced Jul 28, 2026
  • EUDAMED be66d8e2-c707-49aa-8010-bbb769e93eb8 61 fields · synced Jul 28, 2026
  • EUDAMED 78362685-b184-4bc7-9f7a-17b10963e73a 61 fields · synced Aug 2, 2026
  • EUDAMED 32ce7aa8-8a20-4029-839e-646a6d583298 61 fields · synced Sep 18, 2026