Guide Wheel Guide Pin
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Guide Wheel EUDAMEDGuide Wheel Guide Pin FDA UDIDrilling Guide Wheel FDA UDIDrilling Guide Wheel FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDIEndodontic stopper FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / Guide Wheel Guide Pin FDA UDIDental Implant Instrument / Drilling Guide Wheel FDA UDI
- Model / Reference
- DGW8 EUDAMEDFDA UDIDGW12 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDGWGP6 FDA UDI
- Description
- Dental Implant Instrument / Guide Wheel Guide Pin FDA UDIDental Implant Instrument / Drilling Guide Wheel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169140623 EUDAMEDFDA UDI08800053005265 EUDAMEDFDA UDI08806169140661 FDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDIEndodontic stopper 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implantation depth/angle gauge, reusable
Guide Wheel Guide Pin by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 (5)
- FDA UDI 45741588-51c3-4c5b-aced-75dc46fd1744 33 fields · synced Jul 18, 2026
- FDA UDI e4340b06-c895-49dd-ac79-bbbb937ecb64 33 fields · synced May 30, 2026
- FDA UDI 1e5b5812-723e-4aee-81d5-685805e1c090 33 fields · synced May 30, 2026
- EUDAMED 5c8e531f-ede4-4aff-ba69-a1b212b52283 61 fields · synced Jul 15, 2026
- EUDAMED 57b375f3-7cd5-4102-8322-29b03f7d4353 61 fields · synced Jul 18, 2026