Identity
- Trade Name
- ZOLL-DENTAL FDA UDI
- Generic Name
- Dental prosthesis removal instrument FDA UDI
- Device Name
- Custom Finish (SP-XXXX) FDA UDI
- Model / Reference
- CRWN-SP FDA UDI
- Description
- Custom Finish (SP-XXXX) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840105202196 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
No
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
Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis removal instrument.
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- devemed — devemed GmbH · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- STOMA® — Storz am Mark GmbH · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- devemed — devemed GmbH · Class I
- STOMA® — Storz am Mark GmbH · Class I
- TAUB - Trident - IMPULSE — Taub Products · 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
- Zoll-Dental
Sources (1)
- FDA UDI ae02994f-ea52-4a33-a68b-1a76755903ff 34 fields · synced May 30, 2026