Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental soft-tissue coring punch, reusable FDA UDI
- Device Name
- Drilling Instruments EUDAMEDZI MUCOSA PUNCH, D 4.3 FDA UDI
- Model / Reference
- 103.696 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- ZI MUCOSA PUNCH, D 4.3 FDA UDI
Identifiers
- Catalog Number
- 103.696 FDA UDI
- Primary DI / UDI-DI
- 07899878064602 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800084VX EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental soft-tissue coring punch, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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 — 4.3 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Category: Dental soft-tissue coring punch, 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 Dental soft-tissue coring punch, reusable.
- CIRCULAR KNIFE CMU 4.5mm — W.H. Holden, Inc. · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- STOMA® — Storz am Mark GmbH · Class I
- CIRCULAR KNIFE CMU 7.1mm — W.H. Holden, Inc. · Class I
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
- TREPHINE-5mm-LATCH TYPE — W.H. Holden, Inc. · 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 b11776b3-f9ed-400f-93e6-819076c2a52b 37 fields · synced Jul 9, 2026
- EUDAMED 20dc8fed-863e-4458-b649-9faafbc94269 61 fields · synced Jul 9, 2026