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FDA 510(k)

BIOLITE CARBON COATED DENTAL IMPLANT

K-Number: K791491 · 1979-09-04

ApplicantCarbomedics, Inc.
Decision Date1979-09-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOLITE CARBON COATED DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791491. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLITE CARBON COATED DENTAL IMPLANT?

BIOLITE CARBON COATED DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Carbomedics, Inc.. The 510(k) number is K791491.

When did BIOLITE CARBON COATED DENTAL IMPLANT receive FDA 510(k) clearance?

BIOLITE CARBON COATED DENTAL IMPLANT received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791491.

Who is the listed applicant for BIOLITE CARBON COATED DENTAL IMPLANT?

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

What is the FDA product code for BIOLITE CARBON COATED DENTAL IMPLANT?

The FDA product code for BIOLITE CARBON COATED DENTAL IMPLANT is DZE.

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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