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Gem 21s®

FDA UDI

Class III (US FDA UDI)

by Lynch Biologics, Llc

Identity

Trade Name
GEM 21S® FDA UDI
Generic Name
Periodontal root surface regeneration material FDA UDI
Device Name
Growth-Factor Enhanced Matrix for Periodontal Regeneration FDA UDI
Model / Reference
LBGEM05 FDA UDI
Description
Growth-Factor Enhanced Matrix for Periodontal Regeneration FDA UDI

Identifiers

Primary DI / UDI-DI
00850001118002 FDA UDI
PMA Number
P040013 FDA UDI
FDA Product Code
NPZ FDA UDI
NQA FDA UDI
GMDN Term
Periodontal root surface regeneration material FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

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

Dimensions & Sizes

Size
Weight — 0.5 Gram FDA UDI

Category: Periodontal root surface regeneration material

Gem 21s® by Lynch Biologics, Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Periodontal root surface regeneration material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lynch Biologics, Llc

Sources (1)

  • FDA UDI 457b7521-fbca-448d-b068-74c0a7031f94 36 fields · synced May 30, 2026