Identity
- Trade Name
- Perflex Biosens FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Box of 6 Large cartridges 25mm diameter and 98mm long, 28Gr. net of thermoplastic Biosens Standard Pink filled inside of each cartridge sealed in aluminum bag, The cartridges are suitable for 25mm size thermoplastic injectors machines. FDA UDI
- Model / Reference
- Cartridge STD Pink Large 25mm FDA UDI
- Description
- Box of 6 Large cartridges 25mm diameter and 98mm long, 28Gr. net of thermoplastic Biosens Standard Pink filled inside of each cartridge sealed in aluminum bag, The cartridges are suitable for 25mm size thermoplastic injectors machines. FDA UDI
Identifiers
- Catalog Number
- 4112505 FDA UDI
- Primary DI / UDI-DI
- 07290110501556 FDA UDI
- 510(k) Number
- K150454 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
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
Yes
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
Yes
FDA UDI
Category: Dental appliance fabrication material, thermoplastic
Perflex Biosens by Perflex — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
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Cleared under the same submission
K150454 also covers:
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
- Perflex AcryFree — Perflex
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Perflex
Sources (1)
- FDA UDI 0583110d-eae9-4aaa-bd0e-68c31b18d752 36 fields · synced May 30, 2026