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Biosens Disc

FDA UDI

Class II (US FDA UDI)

by Perflex

Identity

Trade Name
Biosens Disc FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Biosens Disc Pink for milling made from Thermoplastic resin 98.4mm Diameter 20mm thickness FDA UDI
Model / Reference
Pink 20mm FDA UDI
Description
Biosens Disc Pink for milling made from Thermoplastic resin 98.4mm Diameter 20mm thickness FDA UDI

Identifiers

Catalog Number
4129820 FDA UDI
Primary DI / UDI-DI
07290110503529 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

Yes

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

Biosens Disc by Perflex — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Perflex

Sources (1)

  • FDA UDI 3d33247b-70f7-4c3f-bc35-b7e32e36daf7 35 fields · synced Jun 8, 2026