Identity
- Trade Name
- CHECK-BITE™ FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- CHECK-BITE™ Anterior Style, No. 75D, Box of 40 FDA UDI
- Model / Reference
- 257540 FDA UDI
- Description
- CHECK-BITE™ Anterior Style, No. 75D, Box of 40 FDA UDI
Identifiers
- Catalog Number
- 257540 FDA UDI
- Primary DI / UDI-DI
- D6582575401 FDA UDI
- 510(k) Number
- K851469 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression tray, single-use 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression tray, single-use
Check-Bite™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
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- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
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- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
Cleared under the same submission
K851469 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
- Gc America Inc.
Sources (1)
- FDA UDI bbd232cb-c3f8-4c8c-98e9-aa564daec295 36 fields · synced May 30, 2026