Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Root Fragment Elevators EUDAMEDRoot fragment elevator "Beck", saw edge F-LINE | SL | double ended FDA UDI
- Model / Reference
- 792-11 F EUDAMEDFDA UDI
- Description
- Root fragment elevator "Beck", saw edge F-LINE | SL | double ended FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644037667 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061644PG08010547 EUDAMED
- Direct Marketing DI
- 04061644037667 EUDAMED
- FDA Product Code
- EMJ FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental elevator, tooth/root 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 elevator, tooth/root
devemed by devemed GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental elevator, tooth/root.
- ROOT ELEVATOR HEIDBRINK #3 EH-LG S/E — W.H. Holden, Inc. · Class I
- ELEVATOR #107 — W.H. Holden, Inc. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Paul Banditt — Terlain Enterprises, 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 ed521d35-77bb-41c9-9268-9870f2febf1d 34 fields · synced Sep 30, 2026
- EUDAMED 8a297d19-e895-44c0-83dd-f3c35e2ef684 61 fields · synced Sep 17, 2026