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Mdk Handpieces

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref MOKO 560K LEDRef MOKO 360K LEDRef MOKO 710NRef MOKO K45KRef MOKO TK45NRef MOKO 750NRef MOKO 350KRef MOKO TN45K LEDRef MOKO 510KRef MOKO 550KRef MOKO 550NRef MOKO N45K LEDRef MOKO 560N LEDRef MOKO 360N LEDRef MOKO 520K LEDRef MOKO 310NRef MOKO 720K LEDRef MOKO 320B LEDRef MOKO 760W LEDRef MOKO 720S LEDRef MOKO 520S LEDRef MOKO 230BRef MOKO 560B LEDRef MOKO 430MRef MOKO 510WRef MOKO 350BRef MOKO 310BRef MOKO 710WRef MOKO 450MRef MOKO 320W LEDRef MOKO 550SRef 260i-LEDRef MOKO 710BRef MOKO 510BRef MOKO 250BRef MOKO 360S LEDRef 260E-B2Ref MOKO 420MRef 260i-B2Ref MOKO 560S LEDRef MOKO 420MTRef MOKO 750KRef 260E-M4Ref MOKO 440MRef 260i-M4Ref MOKO 550BRef MOKO 230BTRef MOKO 430MTRef MOKO 750B

by Mdk Co., Ltd.

Identity

Trade Name
MDK HANDPIECES EUDAMED
Air-Driven Dental Handpieces FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Device Name
ELECTRICAL AIR DRIVEN DENTAL HAND PIECE EUDAMED
Electrical air driven dental handpieces EUDAMED
Model / Reference
MOKO 560K LED EUDAMEDFDA UDI
MOKO 360K LED EUDAMED
MOKO 710N EUDAMED
MOKO K45K EUDAMED
MOKO TK45N EUDAMED
MOKO 750N EUDAMEDFDA UDI
MOKO 350K EUDAMED
MOKO TN45K LED EUDAMEDFDA UDI
MOKO 510K EUDAMED
MOKO 550K EUDAMEDFDA UDI
MOKO 550N EUDAMEDFDA UDI
MOKO N45K LED EUDAMED
MOKO 560N LED EUDAMEDFDA UDI
MOKO 360N LED EUDAMED
MOKO 520K LED EUDAMEDFDA UDI
MOKO 310N EUDAMED
MOKO 720K LED EUDAMEDFDA UDI
MOKO 450M EUDAMEDFDA UDI
MOKO 420M EUDAMEDFDA UDI
MOKO 430M EUDAMEDFDA UDI
MOKO 440M EUDAMEDFDA UDI
260i-LED EUDAMEDFDA UDI
MOKO 520S LED EUDAMEDFDA UDI
MOKO 720S LED EUDAMEDFDA UDI
260E-M4 EUDAMEDFDA UDI
MOKO 750K EUDAMEDFDA UDI
MOKO 420MT EUDAMEDFDA UDI
260i-M4 EUDAMEDFDA UDI
MOKO 430MT EUDAMEDFDA UDI
MOKO 560S LED EUDAMEDFDA UDI
MOKO 320B LED EUDAMED
MOKO 760W LED EUDAMED
MOKO 230B EUDAMED
MOKO 560B LED EUDAMED
MOKO 510W EUDAMED
MOKO 350B EUDAMED
MOKO 310B EUDAMED
MOKO 710W EUDAMED
MOKO 320W LED EUDAMED
MOKO 550S EUDAMED
MOKO 710B EUDAMED
MOKO 510B EUDAMED
MOKO 250B EUDAMED
MOKO 360S LED EUDAMED
260E-B2 EUDAMED
260i-B2 EUDAMED
MOKO 550B EUDAMED
MOKO 230BT EUDAMED
MOKO 750B EUDAMED

Identifiers

Primary DI / UDI-DI
08800027300112 EUDAMED
08800027300259 EUDAMED
08800027300372 EUDAMED
08800027301386 EUDAMED
08800027301355 EUDAMED
08800027300327 EUDAMED
08800027300525 EUDAMED
08800027301362 EUDAMED
08800027300464 EUDAMED
08800027300419 EUDAMED
08800027300426 EUDAMED
08800027301379 EUDAMED
08800027300150 EUDAMED
08800027300211 EUDAMED
08800027300167 EUDAMED
08800027300563 EUDAMED
08800027300068 EUDAMED
08800027300297 EUDAMED
08800027300037 EUDAMED
08800027300075 EUDAMED
08800027300174 EUDAMED
08800027300686 EUDAMED
08800027300143 EUDAMED
08800027300679 EUDAMED
08800027300488 EUDAMED
08800027300549 EUDAMED
08800027300594 EUDAMED
08800027300389 EUDAMED
08800027300716 EUDAMED
08800027300280 EUDAMED
08800027300457 EUDAMED
08800027301256 EUDAMED
08800027300396 EUDAMED
08800027300495 EUDAMED
08800027300723 EUDAMED
08800027300228 EUDAMED
08800027301171 EUDAMED
08800027300617 EUDAMED
08800027301157 EUDAMED
08800027300129 EUDAMED
08800027300631 EUDAMED
08800027300310 EUDAMED
08800027301164 EUDAMED
08800027300693 EUDAMED
08800027301133 EUDAMED
08800027300440 EUDAMED
08800027300662 EUDAMED
08800027300655 EUDAMED
08800027300341 EUDAMED
00880027300426 FDA UDI
00880027300716 FDA UDI
00880027300112 FDA UDI
00880027300617 FDA UDI
00880027300679 FDA UDI
00880027300068 FDA UDI
00880027300419 FDA UDI
00880027300693 FDA UDI
00880027300327 FDA UDI
00880027301256 FDA UDI
00880027300174 FDA UDI
00880027300075 FDA UDI
00880027300167 FDA UDI
00880027301164 FDA UDI
00880027300310 FDA UDI
00880027300150 FDA UDI
00880027300785 FDA UDI
00880027300631 FDA UDI
00880027301133 FDA UDI
00880027300655 FDA UDI
00880027300129 FDA UDI
Basic UDI-DI
B-08800027300112 EUDAMED
B-08800027300259 EUDAMED
B-08800027300372 EUDAMED
B-08800027301386 EUDAMED
B-08800027301355 EUDAMED
B-08800027300327 EUDAMED
B-08800027300525 EUDAMED
B-08800027301362 EUDAMED
B-08800027300464 EUDAMED
B-08800027300419 EUDAMED
B-08800027300426 EUDAMED
B-08800027301379 EUDAMED
B-08800027300150 EUDAMED
B-08800027300211 EUDAMED
B-08800027300167 EUDAMED
B-08800027300563 EUDAMED
B-08800027300068 EUDAMED
B-08800027300297 EUDAMED
B-08800027300037 EUDAMED
B-08800027300075 EUDAMED
B-08800027300174 EUDAMED
B-08800027300686 EUDAMED
B-08800027300143 EUDAMED
B-08800027300679 EUDAMED
B-08800027300488 EUDAMED
B-08800027300549 EUDAMED
B-08800027300594 EUDAMED
B-08800027300389 EUDAMED
B-08800027300716 EUDAMED
B-08800027300280 EUDAMED
B-08800027300457 EUDAMED
B-08800027301256 EUDAMED
B-08800027300396 EUDAMED
B-08800027300495 EUDAMED
B-08800027300723 EUDAMED
B-08800027300228 EUDAMED
B-08800027301171 EUDAMED
B-08800027300617 EUDAMED
B-08800027301157 EUDAMED
B-08800027300129 EUDAMED
B-08800027300631 EUDAMED
B-08800027300310 EUDAMED
B-08800027301164 EUDAMED
B-08800027300693 EUDAMED
B-08800027301133 EUDAMED
B-08800027300440 EUDAMED
B-08800027300662 EUDAMED
B-08800027300655 EUDAMED
B-08800027300341 EUDAMED
510(k) Number
K141886 FDA UDI
FDA Product Code
EFB FDA UDI
EMDN Code
L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMED
L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Mdk Handpieces by Mdk Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Mdk Co., Ltd.
EUDAMED SRN
KR-MF-000042246
Authorised Representative
KTR Europe GmbH DE-AR-000005685

Sources (86)

  • EUDAMED 732d8e34-d6cc-48b1-afff-7da823b6785e 61 fields · synced Sep 17, 2026
  • EUDAMED 11eb8aa2-69d2-422e-93d9-b2ca125c9c2d 61 fields · synced May 11, 2026
  • EUDAMED a86714ee-db09-45c6-934e-b48c728de0a6 61 fields · synced May 16, 2026
  • EUDAMED 83c2a307-1e8c-43b0-a651-abb693cd66e1 61 fields · synced May 16, 2026
  • EUDAMED 3e68a780-72bd-4581-94cc-4c03230253fe 61 fields · synced May 17, 2026
  • EUDAMED 8e867a66-e596-4bb5-aac6-e1a80451afdc 61 fields · synced May 17, 2026
  • EUDAMED c1e033f5-ac63-4185-85dc-b56978afb03c 61 fields · synced May 17, 2026
  • EUDAMED 8c1d8cba-ab65-41b4-87ac-740ff16664c9 61 fields · synced May 17, 2026
  • EUDAMED 49af2c19-bf7b-4d93-a5de-27fa73e23896 61 fields · synced May 17, 2026
  • EUDAMED 69a2a2a2-e7a1-45cb-a31f-333c9992fed8 61 fields · synced May 17, 2026
  • EUDAMED 34363eb1-2eab-4f94-9029-f6e355a98d5a 61 fields · synced May 17, 2026
  • EUDAMED 13fea4ee-c394-4ae5-81de-3b2fe8ae71a1 61 fields · synced May 17, 2026
  • EUDAMED 055edbe8-723c-4e9a-b08b-096918e7297e 61 fields · synced May 17, 2026
  • EUDAMED f74818ca-d3c8-41c3-b69f-9d9f30ddfe8e 61 fields · synced May 17, 2026
  • EUDAMED 4a973fc6-4242-46e6-9dc6-a74beecf66c8 61 fields · synced May 18, 2026
  • EUDAMED 145fda62-e521-4fdb-a976-ef4eabf99b00 61 fields · synced May 18, 2026
  • EUDAMED b84184af-3120-4fc7-bf30-4a823d4322c3 61 fields · synced May 18, 2026
  • FDA UDI 0f6b9d05-1ad5-471c-98b2-718f00a53ad4 33 fields · synced May 25, 2026
  • FDA UDI 82821f58-0959-426c-960d-505cf1b8f0cf 33 fields · synced May 25, 2026
  • FDA UDI 3fc76e89-ad94-4b11-86e3-d439f8ccbba2 33 fields · synced May 25, 2026
  • FDA UDI c1f3c002-1009-4d85-a686-936e34d80d9f 33 fields · synced May 27, 2026
  • FDA UDI 17b58918-b89a-45a3-83fe-cad63642f977 33 fields · synced May 29, 2026
  • FDA UDI 086b74de-5140-48ce-a58a-6af30c1081a9 33 fields · synced May 29, 2026
  • FDA UDI b1653c5c-4dba-4414-91cc-d53d90433532 33 fields · synced May 29, 2026
  • FDA UDI cc4d184b-3872-4e81-a49b-c145ef0c504c 33 fields · synced May 29, 2026
  • FDA UDI 6b0e1cde-fbdf-40ae-94e4-06043228c9ad 33 fields · synced May 29, 2026
  • FDA UDI 67d8d5ec-ab61-460e-bac4-819d10be1167 33 fields · synced May 29, 2026
  • FDA UDI 209b7919-cb58-4fbd-b095-6ec992798386 33 fields · synced May 30, 2026
  • FDA UDI f8aacc72-3c7f-4a1a-a1d4-c5782f192e89 33 fields · synced May 30, 2026
  • FDA UDI 1a172f55-e5bb-449a-9362-6dc8413be450 33 fields · synced May 30, 2026
  • FDA UDI 6acc71da-cce4-48cf-8c3b-db2d3cffc0c4 33 fields · synced May 30, 2026
  • FDA UDI ef3a06a1-a82f-4eba-aca6-67a3d7e2ea28 33 fields · synced May 30, 2026
  • FDA UDI 9c525396-e276-46a3-873d-6129897f31de 33 fields · synced May 30, 2026
  • FDA UDI 30acf3bd-d070-42fa-9687-537c617d3dce 33 fields · synced May 30, 2026
  • FDA UDI 0a3ac3a0-f938-44c8-a74a-9daa73a6bd74 33 fields · synced May 30, 2026
  • FDA UDI 79badc86-b204-44ac-a48b-d9d25a7e8b30 33 fields · synced May 30, 2026
  • FDA UDI 25b027a8-6244-4647-bfd7-ca1e66c5b5b1 33 fields · synced May 30, 2026
  • FDA UDI 719b1b04-074f-4e6a-8699-25f99b88acc5 33 fields · synced May 30, 2026
  • EUDAMED 03349c58-50fa-4283-9879-1e7234129b12 61 fields · synced Jun 20, 2026
  • EUDAMED 6c8a33e0-f73b-4058-81d5-4993b8c91126 61 fields · synced Jun 20, 2026
  • EUDAMED a48c65be-2180-48e3-aceb-b643e9eadfc7 61 fields · synced Jul 8, 2026
  • EUDAMED 864d4b1d-d9bd-4aa5-b053-250cd58210be 61 fields · synced Jul 9, 2026
  • EUDAMED d7d76070-3d2e-4b88-8bf3-031332440f90 61 fields · synced Jul 9, 2026
  • EUDAMED 1e3205ac-a265-4660-b8a0-5ae30bab327a 61 fields · synced Jul 10, 2026
  • EUDAMED dfffcc1b-c90e-4a08-87c8-760de42e06af 61 fields · synced Jul 10, 2026
  • EUDAMED 5e9cd897-3664-46be-bad2-5349fa292e62 61 fields · synced Jul 10, 2026
  • EUDAMED eab844e2-b5e2-4562-9085-4c01a6e04915 61 fields · synced Jul 10, 2026
  • EUDAMED 0ff51ecc-43a8-4349-a90f-fd4cfdb12952 61 fields · synced Jul 10, 2026
  • EUDAMED 05563169-80c4-4d8a-8a23-524ee7d4805b 61 fields · synced Jul 11, 2026
  • EUDAMED 3ca4b3c5-f58e-4fb9-acf6-bcf6ca82d0cb 61 fields · synced Jul 12, 2026
  • EUDAMED ae33d0b8-e6c7-4197-be83-361cd305e6af 61 fields · synced Jul 13, 2026
  • EUDAMED 3c46718d-9af0-4f26-a383-b06e65663410 61 fields · synced Jul 13, 2026
  • EUDAMED 4c4935b9-d130-4e43-9e4b-d3e954f213aa 61 fields · synced Jul 15, 2026
  • EUDAMED 51146b7c-2014-4833-b455-98eb1aecac7d 61 fields · synced Jul 15, 2026
  • EUDAMED c680cc32-5b81-40a5-9bb7-88f9f1c23e39 61 fields · synced Jul 16, 2026
  • EUDAMED 3e630f52-6f05-451f-add9-0313569de5c5 61 fields · synced Jul 17, 2026
  • EUDAMED c1e4b836-80ea-4034-b3c6-b596d0dfc8b0 61 fields · synced Jul 17, 2026
  • EUDAMED 0933c090-c47b-4c80-9be7-342cd1dc02c5 61 fields · synced Jul 17, 2026
  • EUDAMED 855b15d4-c708-47ff-9503-3e3d7e48af50 61 fields · synced Jul 17, 2026
  • EUDAMED c07dc72b-2b65-416b-8cf6-c5544eb4cd74 61 fields · synced Jul 17, 2026
  • EUDAMED f6f34f0e-b948-4693-b070-a64611caa56e 61 fields · synced Jul 17, 2026
  • EUDAMED b60f344a-2cdd-4efd-b3e1-817be4078712 61 fields · synced Jul 18, 2026
  • EUDAMED f186d326-253c-4f63-92ed-cf4d5e1e55bf 61 fields · synced Jul 20, 2026
  • EUDAMED dac39e57-1e79-4b2b-a739-64a65ece60cf 61 fields · synced Jul 20, 2026
  • EUDAMED cb37f91e-f471-40c3-911f-851994271c06 61 fields · synced Jul 20, 2026
  • EUDAMED 980b0514-457e-4154-96e8-10c9ec2fd919 61 fields · synced Jul 22, 2026
  • EUDAMED 8e73ee4b-4bed-443e-b7a9-d489586410eb 61 fields · synced Jul 23, 2026
  • EUDAMED 04407d52-cfc8-46f4-a78f-96064ebf4ddd 61 fields · synced Jul 25, 2026
  • EUDAMED a596dac5-6f44-4a45-8046-bce1860485a7 61 fields · synced Jul 25, 2026
  • EUDAMED 5dcc4c03-0310-4ffc-a0eb-8d9532af8e09 61 fields · synced Jul 26, 2026
  • EUDAMED 2be38f3a-ffa8-4065-b5df-77748a05276e 61 fields · synced Jul 27, 2026
  • EUDAMED f344fd0e-812f-4f83-bbf2-7081f207a8c1 61 fields · synced Jul 27, 2026
  • EUDAMED 604a7465-e55e-4a6f-9d9f-1dad3c1a59ce 61 fields · synced Jul 28, 2026
  • EUDAMED 65b84f4b-2bdc-45e0-a4b2-463ccc93a0aa 61 fields · synced Jul 30, 2026
  • EUDAMED 0acf8b46-996e-4320-90c1-2351945f19b0 61 fields · synced Jul 30, 2026
  • EUDAMED c29432a9-0964-4fa5-8b28-f9b331d71c65 61 fields · synced Jul 30, 2026
  • EUDAMED a25197bd-e2ae-4bed-8762-ab5332277ab7 61 fields · synced Jul 30, 2026
  • EUDAMED 03efc859-3e21-4ee0-aaad-27e84d6134c0 61 fields · synced Jul 31, 2026
  • EUDAMED faddbdf2-cecb-4e7b-9030-6a0637f27970 61 fields · synced Jul 31, 2026
  • EUDAMED b556828e-7119-4d89-ae7c-cdf36937fdf3 61 fields · synced Aug 1, 2026
  • EUDAMED ae47af2a-493e-4377-89df-b91fcd5a4044 61 fields · synced Aug 2, 2026
  • EUDAMED 5b253e0a-08a3-4e2f-a8b7-a67b3f91a675 61 fields · synced Aug 2, 2026
  • EUDAMED 401c6729-387a-4efd-b24a-b081214a48ae 61 fields · synced Aug 3, 2026
  • EUDAMED 47f00de1-c712-4706-9f3e-aa7066e74cd6 61 fields · synced Aug 3, 2026
  • EUDAMED 7732988a-c64c-4bc7-8510-c85333bbf89f 61 fields · synced Aug 3, 2026
  • EUDAMED abde73ae-849a-4d3e-b98a-8c9d1cdba099 61 fields · synced Sep 17, 2026