Identity
- Trade Name
- Perflex Biosens FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 200gr. net filled in jar and packed in box FDA UDI
- Model / Reference
- Purple Pink 200gr. jar FDA UDI
- Description
- Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 200gr. net filled in jar and packed in box FDA UDI
Identifiers
- Catalog Number
- 411008 FDA UDI
- Primary DI / UDI-DI
- 07290110501440 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
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
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
Similar devices
Also classified as Dental appliance fabrication material, thermoplastic.
- Proform — Keystone Industries · U
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Vertex-Dental BV — Vertex-Dental B.V. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
- BioBleach® soft — Dreve Dentamid GmbH · Class I
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 ab210fa6-ab1c-4365-92c8-8683cc694ee8 36 fields · synced May 30, 2026