Identity
- Trade Name
- Wedjets FDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- Wedjet Extra Small FDA UDI
- Model / Reference
- H08040 FDA UDI
- Description
- Wedjet Extra Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661H080401 FDA UDI
- 510(k) Number
- K900844 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, Hevea-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 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
Yes
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: Rubber dam, Hevea-latex
Wedjets by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rubber dam, Hevea-latex.
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- Non-Latex .18/.23mm Medium Royal Blue 6”x 6“ 15pcs — Four D Rubber Company Ltd · Class I
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- Theraband 25 Yard Non-Latex Black CE Mark — The Hygenic Company, LLC · Class I
Cleared under the same submission
K900844 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 I | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI 090542b9-59b2-417f-8dc4-e4a21d95bc2e 35 fields · synced Jun 9, 2026