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Nexcomp A2

FDA UDI

Class II (US FDA UDI)

by Meta Biomed, Inc.

Identity

Trade Name
Nexcomp A2 FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. FDA UDI
Model / Reference
9226 FDA UDI
Description
Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. FDA UDI

Identifiers

Primary DI / UDI-DI
08806387892267 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Nexcomp A2 by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meta Biomed, Inc.

Sources (1)

  • FDA UDI 98697c07-c2ae-4bb6-8d2b-fd68218d3235 34 fields · synced Jun 1, 2026