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Opal Seal

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
Opal Seal FDA UDI
Generic Name
Dental pit/fissure sealant FDA UDI
Device Name
Opal Seal Trial Syringe FDA UDI
Model / Reference
500063 FDA UDI
Description
Opal Seal Trial Syringe FDA UDI

Identifiers

Catalog Number
500063 FDA UDI
Primary DI / UDI-DI
00883205103284 FDA UDI
510(k) Number
K090355 FDA UDI
FDA Product Code
DYH FDA UDI
GMDN Term
Dental pit/fissure sealant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3750 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Category: Dental pit/fissure sealant

Opal Seal by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental pit/fissure sealant.

Cleared under the same submission

K090355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI 4acd3425-e42e-460d-b90c-2e7df58f18ea 37 fields · synced May 30, 2026