Constic OW

FDA UDI

Class II (US FDA UDI)

by DMG Chemisch-Pharmazeutische Fabrik GmbH

Identity

Trade Name: Constic OW FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: Opaque-White FDA UDI
Model / Reference: 220705 FDA UDI
Description: Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: Opaque-White FDA UDI

Identifiers

Catalog Number: 220705 FDA UDI
Primary DI / UDI-DI: EDMG2207050 FDA UDI
510(k) Number: K102603 FDA UDI
FDA Product Code: EBF FDA UDI
EBC FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.3765 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin Dental pit/fissure sealant

Constic OW by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental pit/fissure sealant.

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GLACIER — Sdi , Ltd. · Class II
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Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II

Cleared under the same submission

K102603 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: DMG Chemisch-Pharmazeutische Fabrik GmbH

Sources (1)

FDA UDI 04aee22b-70f6-418c-9a3b-3a467823cf75 37 fields · synced May 31, 2026