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FDA 510(k)

CLEAN AND BOOST

K-Number: K120620 · 2012-05-31

ApplicantApex Dental Materials, Inc.
Decision Date2012-05-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEAN AND BOOST is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2012-05-31 under 510(k) number K120620. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEAN AND BOOST?

CLEAN AND BOOST is a medical device that received FDA 510(k) clearance on 2012-05-31. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K120620.

When did CLEAN AND BOOST receive FDA 510(k) clearance?

CLEAN AND BOOST received FDA 510(k) clearance on 2012-05-31, under 510(k) number K120620.

Who is the listed applicant for CLEAN AND BOOST?

The FDA 510(k) record lists Apex Dental Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEAN AND BOOST?

The FDA product code for CLEAN AND BOOST is KLE.

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Other records listing Apex Dental Materials, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190998BA Pit & Fissure SealantK161077RnD TE and RnD SEK131043APEX UNIVERSAL ADHESIVEK131049ZRPK110859METAL OPAQUERK092539SEAMFREE

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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