DenMat Glutaraldehyde Desensitizer

FDA 510(k) K222357 · Denmat Holding, LLC

Substantially Equivalent

510(k) numberK222357

Submission

Device name
DenMat Glutaraldehyde Desensitizer
Applicant
Denmat Holding, LLC
Lompoc, CA, US
Received
August 4, 2022
Decision date
August 9, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
KLE – Agent, Tooth Bonding, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3200
Specialty
Dental

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Questions and answers

When was DenMat Glutaraldehyde Desensitizer cleared by the FDA?

DenMat Glutaraldehyde Desensitizer (K222357) received a 510(k) decision of Substantially Equivalent on August 9, 2022, 5 days after the submission was received.

What is the product code of K222357?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.