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FDA 510(k)

TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING

K-Number: K885010 · 1989-02-13

ApplicantCoe Laboratories, Inc.
Decision Date1989-02-13
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING is the device name listed in this FDA 510(k) record. The listed applicant is Coe Laboratories, Inc.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K885010. 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 TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING?

TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Coe Laboratories, Inc.. The 510(k) number is K885010.

When did TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING receive FDA 510(k) clearance?

TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING received FDA 510(k) clearance on 1989-02-13, under 510(k) number K885010.

Who is the listed applicant for TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING?

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

What is the FDA product code for TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING?

The FDA product code for TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING is KLE.

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Other records listing Coe Laboratories, 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.

K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSK894282FIRST IMPRESSION TMK894281FIRST IMPRESSION WITH CHLORHEXIDINEK891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTK881422COE PAK AUTO MIX, REGULAR OR HARD SETK881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL

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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

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

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