Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Drilling Instruments EUDAMEDTAPERED DRILL FOR ZYGOMA-S FDA UDI
- Model / Reference
- 103.617 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- TAPERED DRILL FOR ZYGOMA-S FDA UDI
Identifiers
- Catalog Number
- 103.617 FDA UDI
- Primary DI / UDI-DI
- 07899878059868 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800043VH EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 71 Millimeter FDA UDIOuter Diameter — 3.75 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, reusable
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 Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
- Magic Guide Pin — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI ef8490e4-fdee-4ca4-a7a4-62249f853887 36 fields · synced Jun 19, 2026
- EUDAMED 3d276619-91cd-4bfa-8e29-a2f55498086e 61 fields · synced Jun 14, 2026