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FDA 510(k)

SELF CURE BONDING AGENT

K-Number: K962277 · 1996-07-03

ApplicantDent Zar, Inc.
Decision Date1996-07-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF CURE BONDING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dent Zar, Inc.. It received FDA 510(k) clearance on 1996-07-03 under 510(k) number K962277. 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 SELF CURE BONDING AGENT?

SELF CURE BONDING AGENT is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is Dent Zar, Inc.. The 510(k) number is K962277.

When did SELF CURE BONDING AGENT receive FDA 510(k) clearance?

SELF CURE BONDING AGENT received FDA 510(k) clearance on 1996-07-03, under 510(k) number K962277.

Who is the listed applicant for SELF CURE BONDING AGENT?

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

What is the FDA product code for SELF CURE BONDING AGENT?

The FDA product code for SELF CURE BONDING AGENT is KLE.

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Other records listing Dent Zar, 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.

K960729ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)K960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETSK960600LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERSK960595FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETSK960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CUREK960598CONCORD MARYLAND BRIDGE CEMENT

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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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