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BioHorizons

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref CGS-4117Model BioHorizons Dental InstrumentsRef MUCARef CGS-3724Ref IL-STRef BC2258.43TRYRef ODS-XPMRef TRE42Ref CGS-2521Ref GS-TP-GNRef PROPRE28Ref CRCSPModel BioHorizons Conical Dental InstrumentsRef SGDCN

by Biohorizons Implant Systems Inc.

Identity

Trade Name
BioHorizons EUDAMEDFDA UDI
Generic Name
Manual non-rotary dental instrument handle FDA UDI
Fixture/appliance dental drill bit, reusable FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Instrument tray, reusable FDA UDI
Dental soft-tissue coring punch, reusable FDA UDI
Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI
Dental osteotome FDA UDI
Resilient dental precision attachment FDA UDI
Device Name
Surgical Drills (Non-Sterile) EUDAMED
Additional Instruments EUDAMED
Trays (Surgical and Prosthetics) EUDAMED
Try-Ins EUDAMED
Sleeves EUDAMED
Tapered Ridge Expanders EUDAMED
Tissue Punches and Groomers EUDAMED
Conical Scan Components EUDAMED
Impression Components EUDAMED
Angled Multi-unit Abutment Carrier (pack of 3) FDA UDI
Pro Pre Drill, 2.8mm FDA UDI
Tissue Level 4.5mm Direct Pick-up Coping, Non-hexed FDA UDI
CGS Drill, 4.1 x 17mm FDA UDI
Intra-Lock Surgical Tray FDA UDI
Guided Surgery Tissue Punch, Green FDA UDI
Conical Sirona CEREC Scan Post, Regular FDA UDI
Multi-unit 30° Angled Abutment Try-in for CONELOG, Ø3.8/4.3mm, Type A FDA UDI
5.7mm Angled Contour Abutment FDA UDI
CGS Drill, 2.5 x 21mm FDA UDI
Tapered Ridge Expander, 4.2mm FDA UDI
ODSecure Xtend Lab Process Insert (Black) (4 pack) FDA UDI
CGS Drill, 3.7 x 24mm FDA UDI
Model / Reference
MUCA EUDAMEDFDA UDI
PROPRE28 EUDAMEDFDA UDI
SGDCN EUDAMEDFDA UDI
CGS-4117 EUDAMEDFDA UDI
IL-ST EUDAMEDFDA UDI
GS-TP-GN EUDAMEDFDA UDI
CRCSP EUDAMEDFDA UDI
BC2258.43TRY EUDAMEDFDA UDI
CGS-2521 EUDAMEDFDA UDI
TRE42 EUDAMEDFDA UDI
ODS-XPM EUDAMEDFDA UDI
CGS-3724 EUDAMEDFDA UDI
BioHorizons Dental Instruments EUDAMED
BioHorizons Conical Dental Instruments EUDAMED
PBACA FDA UDI
Description
Angled Multi-unit Abutment Carrier (pack of 3) FDA UDI
Pro Pre Drill, 2.8mm FDA UDI
Tissue Level 4.5mm Direct Pick-up Coping, Non-hexed FDA UDI
CGS Drill, 4.1 x 17mm FDA UDI
Intra-Lock Surgical Tray FDA UDI
Guided Surgery Tissue Punch, Green FDA UDI
Conical Sirona CEREC Scan Post, Regular FDA UDI
Multi-unit 30° Angled Abutment Try-in for CONELOG, Ø3.8/4.3mm, Type A FDA UDI
5.7mm Angled Contour Abutment FDA UDI
CGS Drill, 2.5 x 21mm FDA UDI
Tapered Ridge Expander, 4.2mm FDA UDI
ODSecure Xtend Lab Process Insert (Black) (4 pack) FDA UDI
CGS Drill, 3.7 x 24mm FDA UDI

Identifiers

Catalog Number
CRCSP FDA UDI
Primary DI / UDI-DI
00847236006372 EUDAMEDFDA UDI
00847236023829 EUDAMEDFDA UDI
00847236008178 EUDAMEDFDA UDI
00847236001148 EUDAMEDFDA UDI
00847236016609 EUDAMEDFDA UDI
00847236017781 EUDAMEDFDA UDI
00847236025151 EUDAMEDFDA UDI
00847236015787 EUDAMEDFDA UDI
00847236001025 EUDAMEDFDA UDI
00847236012366 EUDAMEDFDA UDI
00847236013318 EUDAMEDFDA UDI
00847236001124 EUDAMEDFDA UDI
00847236013387 FDA UDI
Basic UDI-DI
08472360IIAINST002Q5 EUDAMED
08472360IINST012UK EUDAMED
08472360IINST002UG EUDAMED
08472360IRINST003EW EUDAMED
08472360IINST010UF EUDAMED
08472360IRINST001ES EUDAMED
08472360IIAINST006QD EUDAMED
08472360IINST020UJ EUDAMED
08472360IINST004UL EUDAMED
Direct Marketing DI
00847236019235 EUDAMED
00847236019211 EUDAMED
00847236018979 EUDAMED
00847236019082 EUDAMED
00847236019648 EUDAMED
00847236022136 EUDAMED
510(k) Number
K071638 FDA UDI
K223697 FDA UDI
FDA Product Code
NDP FDA UDI
NHA FDA UDI
EMDN Code
Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term
Manual non-rotary dental instrument handle FDA UDI
Fixture/appliance dental drill bit, reusable FDA UDI
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Instrument tray, reusable FDA UDI
Dental soft-tissue coring punch, reusable FDA UDI
Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Dental implant suprastructure, permanent, preformed FDA UDI
Dental osteotome FDA UDI
Resilient dental precision attachment FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3980 FDA UDI
872.3630 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

Yes

EUDAMEDEUDAMED

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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Manual non-rotary dental instrument handle

BioHorizons by Biohorizons Implant Systems Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Manual non-rotary dental instrument handle.

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
Biohorizons Implant Systems Inc.

Sources (25)

  • FDA UDI 3dec503b-ee7a-4bb7-bc81-5dae25d6c99a 33 fields · synced Oct 1, 2026
  • FDA UDI 92628445-0573-4260-bc5e-8ab97276c1e6 33 fields · synced May 30, 2026
  • FDA UDI ed7c59d2-f5f6-4042-a025-d4144b7217c3 33 fields · synced May 30, 2026
  • FDA UDI 12b2463d-40e1-4282-83fd-b8d805cfe8ac 33 fields · synced May 30, 2026
  • FDA UDI 8ac3b148-1b84-4b50-86ed-1c65bac178ef 33 fields · synced May 30, 2026
  • FDA UDI bba2cd42-ec5b-4dc8-b8d2-3fa04a62ff0c 33 fields · synced May 30, 2026
  • FDA UDI 46e5988c-aab5-40e7-8ac2-c99c3ba3428f 34 fields · synced May 30, 2026
  • FDA UDI ea18e9e1-2a12-4235-8e99-023ea9b8e211 33 fields · synced May 30, 2026
  • FDA UDI bf99a75f-20ab-484e-ad6c-5e3115f95b85 34 fields · synced May 30, 2026
  • FDA UDI 6c309a2b-6d52-4be8-b2b6-d36718b02d18 33 fields · synced May 30, 2026
  • FDA UDI 1686a647-40ca-4eda-9d84-68208a7722e2 33 fields · synced May 30, 2026
  • FDA UDI 7b617a94-f9ed-4f8a-a923-94f4a3dece94 33 fields · synced May 30, 2026
  • FDA UDI 53c4d218-e041-4a4c-9fe2-bc0e2579d40e 33 fields · synced May 30, 2026
  • EUDAMED f7012a99-790b-4203-91f3-24b21dd41bcc 61 fields · synced Sep 17, 2026
  • EUDAMED 9142f9d3-91a9-4398-a7d8-2c110f631cf9 61 fields · synced Sep 17, 2026
  • EUDAMED 217c5c95-95fc-4226-be7e-adfead800122 61 fields · synced Sep 17, 2026
  • EUDAMED e84694bc-e4ab-4470-81fd-3512157b024a 61 fields · synced Sep 17, 2026
  • EUDAMED fb50ed79-c4ed-4dcd-bf81-be9ad7dccbec 61 fields · synced Sep 17, 2026
  • EUDAMED a11e74a4-597d-4855-8f38-476d4b12ba32 61 fields · synced Sep 18, 2026
  • EUDAMED 773d3477-f3d4-4551-b6c4-bc9f99271959 61 fields · synced Sep 18, 2026
  • EUDAMED f6151446-22a1-4642-bc96-8d85ef12cae8 61 fields · synced Sep 18, 2026
  • EUDAMED 35b1f797-6c7e-4819-bf94-81da30ef32b7 61 fields · synced Sep 18, 2026
  • EUDAMED 554e05f3-ee6e-4095-b6a0-9e8334e84673 61 fields · synced Sep 18, 2026
  • EUDAMED 3a98029f-4254-4b02-a7ba-1730cc449e43 61 fields · synced Sep 30, 2026
  • EUDAMED fcb2ab72-c838-464d-a682-9029ed5a5dbf 61 fields · synced Oct 1, 2026