Identity
- Trade Name
- Duraflex FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Natural Pink Disc, 98mm x 20mm FDA UDI
- Model / Reference
- DFDISC-NP-98-20 FDA UDI
- Description
- Natural Pink Disc, 98mm x 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326104693 FDA UDI
- 510(k) Number
- K063626 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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: Dental appliance fabrication material, thermoplastic
Duraflex by The Myerson Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, thermoplastic.
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Cleared under the same submission
K063626 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
Sources (2)
- FDA UDI e62f0e86-c82c-42cf-8871-7631aacaf942 35 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 1, 2026