Consepsis

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name: Consepsis FDA UDI
Generic Name: Dental tooth-cleaning solution FDA UDI
Device Name: Consepsis Unit Dose 50pk FDA UDI
Model / Reference: 7665 FDA UDI
Description: Consepsis Unit Dose 50pk FDA UDI

Identifiers

Catalog Number: 7665 FDA UDI
Primary DI / UDI-DI: 00883205102607 FDA UDI
510(k) Number: K924982 FDA UDI
FDA Product Code: LBH FDA UDI
GMDN Term: Dental tooth-cleaning solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3260 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

Yes

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 tooth-cleaning solution

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

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Cleared under the same submission

K924982 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: Ultradent Products, Inc.

Sources (1)

FDA UDI 5bb2a0af-034d-4ae2-add4-f6e2775d2c6c 37 fields · synced Jun 1, 2026