Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- Drilling Instruments EUDAMEDDRILL EXTENSION FDA UDI
- Model / Reference
- 103.091 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- DRILL EXTENSION FDA UDI
Identifiers
- Catalog Number
- 103.091 FDA UDI
- Primary DI / UDI-DI
- 07898237561516 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800134VM EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
- GMDN Term
- Dental drill bit extension FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental drill bit extension
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental drill bit extension.
- Dríva™ Gold Series Drills — BIOMET 3I, LLC · Class I
- Zuga — Zuga Medical, Inc. · Class II
- Restore — Keystone Dental Inc. · Class II
- Drill Extension — Ossvis Co., Ltd. · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- Tapered Screw-Vent® — ZIMMER DENTAL INC. · Class I
- Mount Extension — POINTIMPLANT Co., Ltd. · Class I
- Tapered Screw-Vent® — ZIMMER DENTAL INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI 0965f878-1bf2-430a-b16e-d5d9a7666635 36 fields · synced Jul 28, 2026
- EUDAMED b898a720-4c5c-4c2e-972a-6ee463a22f6a 61 fields · synced Jul 28, 2026