Identity
- Trade Name
- StoneBite® scan FDA UDI
- Generic Name
- Bite registration rim wax FDA UDI
- Device Name
- No. FDA UDI
- Model / Reference
- D504870 FDA UDI
- Description
- No. FDA UDI
Identifiers
- Catalog Number
- D504870 FDA UDI
- Primary DI / UDI-DI
- E239D5048701 FDA UDI
- 510(k) Number
- K190571 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Bite registration rim wax FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bite registration rim wax
StoneBite® scan by Dreve Dentamid GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bite registration rim wax.
- Bite Rim Sticks — YAMAHACHI DENTAL MFG., CO. · Class I
- Bite Occlusion Rims - Wax — Denplus Inc · Class I
- Take 1 Advanced — KERR CORPORATION · Class II
- ROGSON WAX, MDC Dental — MDC DENTAL · Class I
- Hexa — Hexa Dental · Class II
- ALMORE BITE REGISTRATION TABS — Hager Worldwide, Inc. · Class I
- Nobilium — CMP INDUSTRIES LLC · Class I
- Laminated Bite Wafers-Wax — Denplus Inc · Class I
Cleared under the same submission
K190571 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dreve Dentamid GmbH
Sources (1)
- FDA UDI 38024476-71b8-4443-8c26-feb98104d8f8 37 fields · synced May 30, 2026