Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Osteotomes EUDAMEDOsteotome | Ø 2.0 < 2.7 mm bayonet, concave F-LINE | RS FDA UDI
- Model / Reference
- 2825-27 F EUDAMEDFDA UDI
- Description
- Osteotome | Ø 2.0 < 2.7 mm bayonet, concave F-LINE | RS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644032587 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061644PG01040223 EUDAMED
- Direct Marketing DI
- 04061644032587 EUDAMED
- FDA Product Code
- EMM FDA UDI
- EMDN Code
- L150101 ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental osteotome
devemed by devemed GmbH — 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
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- 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
- KANER SPREADER 7.5mm — W.H. Holden, Inc. · 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
- Manufacturer
- devemed GmbH
Sources (2)
- FDA UDI 0cc86edf-0ba8-46cb-887d-96dda6ce35e9 34 fields · synced Aug 1, 2026
- EUDAMED 4d328ebb-6359-4de1-bd4a-00ccbd5d5acc 61 fields · synced Aug 1, 2026