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FDA 510(k)

REVOLUTION BOND

K-Number: K953592 · 1995-09-07

ApplicantE&D Dental Products, Inc.
Decision Date1995-09-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REVOLUTION BOND is the device name listed in this FDA 510(k) record. The listed applicant is E&D Dental Products, Inc.. It received FDA 510(k) clearance on 1995-09-07 under 510(k) number K953592. 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 REVOLUTION BOND?

REVOLUTION BOND is a medical device that received FDA 510(k) clearance on 1995-09-07. The listed applicant is E&D Dental Products, Inc.. The 510(k) number is K953592.

When did REVOLUTION BOND receive FDA 510(k) clearance?

REVOLUTION BOND received FDA 510(k) clearance on 1995-09-07, under 510(k) number K953592.

Who is the listed applicant for REVOLUTION BOND?

The FDA 510(k) record lists E&D Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOLUTION BOND?

The FDA product code for REVOLUTION BOND is KLE.

Related Clinical Trials

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.

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Other records listing E&D Dental Products, 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.

K922633CAVI-ZYMEK912820POLYESTER RESIN HAND MOLDED TRAY

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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