Capo Universal, 6 g

FDA UDI

Class II (US FDA UDI)

by Schütz Dental GmbH

Identity

Trade Name: Capo Universal, 6 g FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. FDA UDI
Model / Reference: 232054 FDA UDI
Description: Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. FDA UDI

Identifiers

Primary DI / UDI-DI: ESDG2320541 FDA UDI
FDA Product Code: EMA FDA UDI
EBC FDA UDI
EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
872.3765 FDA UDI
872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Category: Dental composite resin

Capo Universal, 6 g by Schütz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
Forma S — ULTRADENT PRODUCTS, INC. · Class II
NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
SimpliShade — KERR CORPORATION · Class II
Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
CLEARFIL MAJESTY ES Flow Universal　Low (U) — Kuraray Noritake Dental Inc. Kurashiki · Class IIa

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: Schütz Dental GmbH

Sources (1)

FDA UDI 83dcefe9-656e-4020-bc30-7a090b036cbd 34 fields · synced May 30, 2026