Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Instruments for Bone Grafting and Sinus Lift EUDAMEDCONCAVE OSTEOTOME FDA UDI
- Model / Reference
- 110.156 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- CONCAVE OSTEOTOME FDA UDI
Identifiers
- Catalog Number
- 110.156 FDA UDI
- Primary DI / UDI-DI
- 07899878001102 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800063VP EUDAMED
- FDA Product Code
- EMM FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDI
Category: Dental osteotome
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 osteotome.
- J & J INSTRUMENTS — J&J Instruments, LLC · Class I
- OSTEOTOME REPLACE - 5.0mm - CONCAVE O/S HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- devemed — devemed GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
- OSTEOTOME — KLS-Martin L.P. · Class I
- OSTEOTOME REPLACE - 6.0mm - RADIUS HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · 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 83ba22bc-71ee-4f74-9157-6279c096db1d 37 fields · synced Jul 9, 2026
- EUDAMED f62e67a6-0575-4daf-8730-fb6139d11597 61 fields · synced Jul 9, 2026