perFORM™

FDA UDI

Class II (US FDA UDI)

by Orthocell Limited

Identity

Trade Name: perFORM™ FDA UDI
Generic Name: Collagen dental regeneration membrane FDA UDI
Model / Reference: perf2030 FDA UDI

Identifiers

Primary DI / UDI-DI: 09358206000098 FDA UDI
510(k) Number: K201241 FDA UDI
FDA Product Code: NPL FDA UDI
GMDN Term: Collagen dental regeneration membrane FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Width — 20 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Collagen dental regeneration membrane

perFORM™ by Orthocell Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Collagen dental regeneration membrane.

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PLENA FLEX — COLLAGEN MATRIX, INC. · Class II
Neogen Collagen Firm L — COLLAGEN MATRIX, INC. · Class II
OUSIA bioMAINTAIN — ACE SURGICAL SUPPLY CO., INC. · Class II
ORAFOAM-PKG-18 — SALVIN DENTAL SPECIALTIES, LLC · Class II
Kontour Matrix — Matricel GmbH · Class II
Reguarde — COLLAGEN MATRIX, INC. · Class II

Cleared under the same submission

K201241 also covers:

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

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Manufacturer

Manufacturer: Orthocell Limited

Sources (1)

FDA UDI e4795ef4-6b61-4947-9548-af46f2a50f4e 34 fields · synced May 30, 2026