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FDA 510(k)

BELLEGLAZE

K-Number: K992067 · 1999-08-27

ApplicantKerr Dental Materials Center
Decision Date1999-08-27
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELLEGLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K992067. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLEGLAZE?

BELLEGLAZE is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K992067.

When did BELLEGLAZE receive FDA 510(k) clearance?

BELLEGLAZE received FDA 510(k) clearance on 1999-08-27, under 510(k) number K992067.

Who is the listed applicant for BELLEGLAZE?

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

What is the FDA product code for BELLEGLAZE?

The FDA product code for BELLEGLAZE is EBD.

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Other records listing Kerr Dental Materials Center as applicant

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Related Devices (Code: EBD)

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.

K254091GLOSSY COAT (15ML)YAMAHACHI DENTAL MFG., Co.K250804ID LIGHT CURE SYSTEMId Korea Co., Ltd.K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KGK223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-PakK211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & COK162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH

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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