Identity
- Trade Name
- Laminated Bite Wafers-Wax FDA UDI
- Generic Name
- Bite registration rim wax FDA UDI
- Device Name
- Laminated Bite Wafers-Wax, White, 35 units FDA UDI
- Model / Reference
- 3003102 FDA UDI
- Description
- Laminated Bite Wafers-Wax, White, 35 units FDA UDI
Identifiers
- Catalog Number
- 3003102 FDA UDI
- Primary DI / UDI-DI
- D8453003102 FDA UDI
- FDA Product Code
- EGD FDA UDI
- GMDN Term
- Bite registration rim wax FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Safe FDA UDI
Category: Bite registration rim wax
Laminated Bite Wafers-Wax by Denplus Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bite registration rim wax.
- StoneBite® — Dreve Dentamid GmbH · Class II
- Bite Rim Sticks — YAMAHACHI DENTAL MFG., CO. · Class I
- StoneBite® Introduction Package — Dreve Dentamid GmbH · Class II
- 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
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
- Denplus Inc
Sources (1)
- FDA UDI 473ec03c-830c-4699-b944-5c042eb08a2e 34 fields · synced May 31, 2026