Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Surgically Invasive Accessories EUDAMED7.0 DRILL STOP D6.0/7.0 HELIX SHORT FDA UDI
- Model / Reference
- 125.191 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- 7.0 DRILL STOP D6.0/7.0 HELIX SHORT FDA UDI
Identifiers
- Catalog Number
- 125.191 FDA UDI
- Primary DI / UDI-DI
- 07899878058267 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800054VN EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 7.0 Millimeter FDA UDILumen/Inner Diameter — 7.1 Millimeter FDA UDI
Category: Surgical drill guide, 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 Surgical drill guide, reusable.
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- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, 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
Sources (2)
- FDA UDI f230fe9e-9f8f-42b9-b11f-5aa9065aac43 36 fields · synced Jun 19, 2026
- EUDAMED 43921aff-59c6-481c-bc19-e5750b5a5dc5 61 fields · synced Jun 19, 2026