Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental implantation drilling template stabilization bolt FDA UDI
- Device Name
- Clamp & Stabilizer EUDAMEDZI GUIDE ESTABILIZER FOR GUIDED SURGERY FDA UDI
- Model / Reference
- 125.209 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- ZI GUIDE ESTABILIZER FOR GUIDED SURGERY FDA UDI
Identifiers
- Catalog Number
- 125.209 FDA UDI
- Primary DI / UDI-DI
- 07899878064688 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800059VY EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implantation drilling template stabilization bolt FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 4.52 Millimeter FDA UDILength — 13.3 Millimeter FDA UDI
Category: Dental implantation drilling template stabilization bolt
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 implantation drilling template stabilization bolt.
- OneGuide Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- OneGuide KS Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- OneGuide Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- OneGuide Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- Vertical Anchor — POINTIMPLANT Co., Ltd. · Class I
- OneGuide KS Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- OneGuide Implant Anchor — OSSTEM IMPLANT Co., Ltd. · Class I
- OneGuide TS Implant Anchor — OSSTEM 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 064ef16b-2854-41d2-b21e-c6c42f87ed00 37 fields · synced Jul 31, 2026
- EUDAMED 5b23432e-e66d-4d5a-b492-eec3c2e26404 61 fields · synced Jul 31, 2026