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122 Taper Drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 122TPD5515Ref 122TPD4006Ref 122TPD4508Ref 122TPD4013Ref 122TPD3513Ref 122TPD6013Ref 122TPD5006Ref 122TPD4007Ref 122TPD4011Ref 122TPD4008Ref 122TPD3515Ref 122TPD4505Ref 122TPD4504Ref 122TPD5013Ref 122TPD4004Ref 122TPD4507Ref 122TPD4005Ref 122TPD6008Ref 122TPD5506Ref 122TPD5508Ref 122TPD7007Ref 122TPD7011Ref 122TPD5507Ref 122TPD5511Ref 122TPD7006
Identity
- Trade Name
- 122 Taper Drill EUDAMEDFDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Surgical Drill System EUDAMED
- Model / Reference
- 122TPD5515 EUDAMEDFDA UDI122TPD7006 EUDAMEDFDA UDI122TPD6013 EUDAMEDFDA UDI122TPD3513 EUDAMEDFDA UDI122TPD4008 EUDAMEDFDA UDI122TPD5511 EUDAMEDFDA UDI122TPD7007 EUDAMEDFDA UDI122TPD5506 EUDAMEDFDA UDI122TPD7011 EUDAMEDFDA UDI122TPD4507 EUDAMEDFDA UDI122TPD4011 EUDAMEDFDA UDI122TPD4006 EUDAMEDFDA UDI122TPD4004 EUDAMEDFDA UDI122TPD5006 EUDAMEDFDA UDI122TPD5507 EUDAMEDFDA UDI122TPD4007 EUDAMEDFDA UDI122TPD4013 EUDAMEDFDA UDI122TPD4508 EUDAMEDFDA UDI122TPD4504 EUDAMEDFDA UDI122TPD4005 EUDAMEDFDA UDI122TPD6008 EUDAMEDFDA UDI122TPD5013 EUDAMEDFDA UDI122TPD4505 EUDAMEDFDA UDI122TPD3515 EUDAMEDFDA UDI122TPD5508 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000982045 EUDAMEDFDA UDI08809917169280 EUDAMEDFDA UDI08809917169273 EUDAMEDFDA UDI08809917168917 EUDAMEDFDA UDI08809917168795 EUDAMEDFDA UDI08809917169204 EUDAMEDFDA UDI08809917169297 EUDAMEDFDA UDI08809917169167 EUDAMEDFDA UDI08809917169327 EUDAMEDFDA UDI08809917169037 EUDAMEDFDA UDI08809917168979 EUDAMEDFDA UDI08809917168955 EUDAMEDFDA UDI08809917168931 EUDAMEDFDA UDI08809917169099 EUDAMEDFDA UDI08809917169174 EUDAMEDFDA UDI08809917168962 EUDAMEDFDA UDI08809917168986 EUDAMEDFDA UDI08809917169044 EUDAMEDFDA UDI08809917169006 EUDAMEDFDA UDI08809917168948 EUDAMEDFDA UDI08809917169242 EUDAMEDFDA UDI08809917168849 EUDAMEDFDA UDI08809917169013 EUDAMEDFDA UDI08809917168924 EUDAMEDFDA UDI08809917169181 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406DRILLH5 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Market of Registration
- Czechia 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
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 UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
122 Taper Drill by Osstem Implant Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406DRILLH5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (50)
- EUDAMED 9c7ebbf6-b2ce-453e-acbf-2e9696eb2ba9 61 fields · synced Aug 4, 2026
- FDA UDI bdf670cf-1127-49a8-99b2-338551858a91 32 fields · synced May 27, 2026
- FDA UDI 7b580818-08d1-4549-87e9-36118e5ce4a1 32 fields · synced May 27, 2026
- FDA UDI a6216e47-1ea0-467e-aab7-f01046015327 32 fields · synced May 29, 2026
- FDA UDI 75a9f2ee-3814-48ad-83bb-e742b17b7b04 32 fields · synced May 29, 2026
- FDA UDI 4b62604d-bf33-4865-b095-ecda6217ff33 32 fields · synced May 29, 2026
- FDA UDI c7180845-a39b-4e9a-aac4-eaf2f5cfdaf8 32 fields · synced May 30, 2026
- FDA UDI 6550adf0-a699-4b84-a8f1-5410780fd49f 32 fields · synced May 30, 2026
- FDA UDI bfd4da9f-3748-4385-be78-553aa84802b0 32 fields · synced May 30, 2026
- FDA UDI d719e647-3602-49ef-94ae-69c3454c2dbb 32 fields · synced May 30, 2026
- FDA UDI 561fc16f-dcda-4fb9-81cd-6c81384e8895 32 fields · synced May 30, 2026
- FDA UDI cac3b7bf-4d03-47a7-af9a-3a6df89311ff 32 fields · synced May 30, 2026
- FDA UDI debca19d-8a6f-4048-9e67-6e4351e83fc7 32 fields · synced May 30, 2026
- FDA UDI 668a1316-2ff6-41cb-a427-4c51edcab8e1 32 fields · synced May 30, 2026
- FDA UDI a420ad76-263c-4242-ad2e-979e3a2d390d 32 fields · synced May 30, 2026
- FDA UDI 65c0cc03-fea5-4c04-a389-d057d540ca1e 32 fields · synced May 30, 2026
- FDA UDI 2a755236-0921-4119-83de-30073ad01df5 32 fields · synced May 30, 2026
- FDA UDI edfd77a2-8893-47a9-8b88-37818037a666 32 fields · synced May 30, 2026
- FDA UDI c7e6176e-a787-4937-96d3-ebfba777aa10 32 fields · synced May 30, 2026
- FDA UDI d1d3280e-13c5-4387-9462-5b16c79c0828 32 fields · synced May 30, 2026
- FDA UDI dfdf3c2e-32be-4c64-b42c-10ecd324cf3a 32 fields · synced May 30, 2026
- FDA UDI 8cfed8ea-ac33-4365-b5d3-5f87870f566c 32 fields · synced May 30, 2026
- FDA UDI c90691c0-71d5-4b16-8892-7c48d596460e 32 fields · synced May 30, 2026
- FDA UDI 6035c23c-c442-48d6-af1a-5d1919de90bb 32 fields · synced May 30, 2026
- FDA UDI 253e3154-ffc3-4a55-bab5-f379210be565 32 fields · synced May 30, 2026
- FDA UDI 8d550b0a-4f4a-40b2-8500-0f622f41b70e 32 fields · synced May 30, 2026
- EUDAMED 9169270a-f259-404f-91f5-eda6e69222e5 61 fields · synced Jun 20, 2026
- EUDAMED 8088cc6d-37ac-42e8-94b9-9b69545ba9b0 61 fields · synced Jul 9, 2026
- EUDAMED 1f7ffd99-6b4d-4129-bcfc-8d260bb207d0 61 fields · synced Jul 9, 2026
- EUDAMED 8332975b-33d5-4e59-a4b0-f70dbd37ad62 61 fields · synced Jul 10, 2026
- EUDAMED 040d521d-d0c3-4c48-8011-0cc1689fcc56 61 fields · synced Jul 10, 2026
- EUDAMED 4f4bc7c4-ba66-44f1-a9f8-43805312a13b 61 fields · synced Jul 10, 2026
- EUDAMED 6e5ef269-23b0-455a-bc2c-a253a7b85a11 61 fields · synced Jul 11, 2026
- EUDAMED efe80891-f101-4ba6-901f-c15e82f34382 61 fields · synced Jul 14, 2026
- EUDAMED 588eaa62-c93a-4de6-92ba-66c5a6c9ea36 61 fields · synced Jul 16, 2026
- EUDAMED a5bbd7c4-7db7-4a87-95d1-d24bb41edc5f 61 fields · synced Jul 17, 2026
- EUDAMED 5234d284-2726-4eee-ba53-63905e57519d 61 fields · synced Jul 18, 2026
- EUDAMED 55498f08-8fb6-4740-907b-756647062a70 61 fields · synced Jul 20, 2026
- EUDAMED 36b00e22-7736-4b8f-b23e-eb3598bf24bc 61 fields · synced Jul 21, 2026
- EUDAMED 5c729e7b-59d7-4985-8d6e-4d3b0431faa6 61 fields · synced Jul 26, 2026
- EUDAMED 00b7d96f-69cc-443a-b60c-2211d7c564ba 61 fields · synced Jul 26, 2026
- EUDAMED 7093bc1e-6e5d-4a88-aef3-f3a211b6ff32 61 fields · synced Jul 26, 2026
- EUDAMED a7dc4b34-f771-4211-943f-c413d09251c4 61 fields · synced Jul 27, 2026
- EUDAMED 7823d014-ce78-4a79-a71b-c1ca7b2abf3d 61 fields · synced Jul 28, 2026
- EUDAMED da71c39b-d3c2-4018-ac3a-104435c7036b 61 fields · synced Jul 30, 2026
- EUDAMED 387b600b-b715-4c6c-bbe2-5ede0f694ff1 61 fields · synced Jul 30, 2026
- EUDAMED c093483d-8622-4f58-b052-9d429b1e797a 61 fields · synced Jul 30, 2026
- EUDAMED 801cc2db-ba33-4a8e-bdca-8a08d50f77ec 61 fields · synced Jul 31, 2026
- EUDAMED 46c520c5-ea52-49e7-94b0-59a8ea3f0a94 61 fields · synced Aug 3, 2026
- EUDAMED 75ef447b-5692-481f-9a16-b531bd67b0e3 61 fields · synced Aug 4, 2026