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Hex Driver for Ratchet
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DRHDL12Model DENTIS Implant Surgical Instrument SystemRef DRHDES12Ref DRHDES125Ref DRHD35125Ref DRHDS12Ref DRHDEL12Ref DRHDL09Ref DRHD2312
Identity
- Trade Name
- Hex Driver for Ratchet EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDIDental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / Hex Driver for Ratchet FDA UDIDental Implant Instrument / DRHDL12 FDA UDI
- Model / Reference
- DRHDS12 EUDAMEDFDA UDIDRHD2312 EUDAMEDFDA UDIDRHDL12 EUDAMEDFDA UDIDRHD35125 EUDAMEDFDA UDIDRHDL09 EUDAMEDFDA UDIDRHDES125 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDRHDES12 EUDAMEDDRHDEL12 EUDAMEDDRD125S FDA UDI
- Description
- Dental Implant Instrument / Hex Driver for Ratchet FDA UDIDental Implant Instrument / DRHDL12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169139184 EUDAMEDFDA UDI08806169139214 EUDAMEDFDA UDI08806169139191 EUDAMEDFDA UDI08806169139283 EUDAMEDFDA UDI08806169139160 EUDAMEDFDA UDI08806169139238 EUDAMEDFDA UDI08806169139177 EUDAMED08806169139207 EUDAMED08806169139146 FDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDIDental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDIFDA 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Hex Driver for Ratchet by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (15)
- FDA UDI 041a4013-5f36-496b-8944-4242ebde3699 33 fields · synced Aug 2, 2026
- FDA UDI e0bd4783-19e6-4133-924c-086569dea038 33 fields · synced May 29, 2026
- FDA UDI 9dbfbcd1-bcba-4549-873f-b4642d116490 33 fields · synced May 30, 2026
- FDA UDI 45e1d5c0-b360-4c53-a4af-efb1b845a961 33 fields · synced May 30, 2026
- FDA UDI 863dc89c-97a7-4e0c-8765-60ba0e3a3781 33 fields · synced May 30, 2026
- FDA UDI 22dd9b12-2f97-4663-aec2-48f8489e486a 33 fields · synced May 30, 2026
- FDA UDI 47975847-aacb-4865-8168-4d6a97bf055f 33 fields · synced May 30, 2026
- EUDAMED 31bd3764-a51c-45b4-9bf0-bfea63dd870e 61 fields · synced Jul 8, 2026
- EUDAMED 4cdc9079-f3b2-4250-8b8a-b11d941d32d6 61 fields · synced Jul 9, 2026
- EUDAMED afa26018-0a97-4195-9335-a93006365e1f 61 fields · synced Jul 17, 2026
- EUDAMED 8a79e2a3-cb51-4ff7-9963-fdaf69016c00 61 fields · synced Jul 20, 2026
- EUDAMED 618f8dc9-8437-486a-9905-179fcaa881a1 61 fields · synced Jul 22, 2026
- EUDAMED d808382c-9c36-458b-b445-5a2284bd9c7e 61 fields · synced Jul 25, 2026
- EUDAMED 7bd9f428-e2ba-46db-a216-b797eeb606db 61 fields · synced Jul 25, 2026
- EUDAMED 625d3cdf-a3c6-49e5-9fce-03fc2b3bfbd9 61 fields · synced Aug 2, 2026