Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Dental prosthesis removal instrument FDA UDI
- Device Name
- Crown spreader | 16.0 cm for premolars and molars F-LINE | PH FDA UDI
- Model / Reference
- 7109-20 F FDA UDI
- Description
- Crown spreader | 16.0 cm for premolars and molars F-LINE | PH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644038183 FDA UDI
- FDA Product Code
- EIS FDA UDI
- GMDN Term
- Dental prosthesis removal instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 prosthesis removal instrument
Devemed Crown Spreader: A reliable and effective instrument for removing permanent or temporary cemented dental prosthesis restorations, particularly from premolars and molars. This non-electric, hand-held device is designed for single use only.
Similar devices
Also classified as Dental prosthesis removal instrument.
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- STOMA® — Storz am Mark GmbH · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- STOMA® — Storz am Mark GmbH · Class I
- TAUB - Trident - IMPULSE — Taub Products · Class I
- STOMA® — Storz am Mark GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- devemed GmbH
Sources (1)
- FDA UDI 641c57ad-5699-4ee0-b4c2-f33c152700da 34 fields · synced Jul 23, 2026