Identity
- Trade Name
- EdgeDam™ Sample Heavy 6x6 Latex-Free FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- Premium Polyisoprene Dental Dam FDA UDI
- Model / Reference
- 978382-E FDA UDI
- Description
- Premium Polyisoprene Dental Dam FDA UDI
Identifiers
- Catalog Number
- EDLFSH66 FDA UDI
- Primary DI / UDI-DI
- 00359883006754 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, non-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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 36 Square inch FDA UDI
Category: Rubber dam, non-latex
EdgeDam™ Sample Heavy 6x6 Latex-Free by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 266dbfe2-2710-45e0-9558-9c25d73f7029 37 fields · synced Jun 9, 2026