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FDA 510(k)

DB PRECISION IMPLANT SYSTEM, 2000 SERIES

K-Number: K860982 · 1986-04-25

ApplicantDriskell Bioengineering
Decision Date1986-04-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DB PRECISION IMPLANT SYSTEM, 2000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Driskell Bioengineering. It received FDA 510(k) clearance on 1986-04-25 under 510(k) number K860982. 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 DB PRECISION IMPLANT SYSTEM, 2000 SERIES?

DB PRECISION IMPLANT SYSTEM, 2000 SERIES is a medical device that received FDA 510(k) clearance on 1986-04-25. The listed applicant is Driskell Bioengineering. The 510(k) number is K860982.

When did DB PRECISION IMPLANT SYSTEM, 2000 SERIES receive FDA 510(k) clearance?

DB PRECISION IMPLANT SYSTEM, 2000 SERIES received FDA 510(k) clearance on 1986-04-25, under 510(k) number K860982.

Who is the listed applicant for DB PRECISION IMPLANT SYSTEM, 2000 SERIES?

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

What is the FDA product code for DB PRECISION IMPLANT SYSTEM, 2000 SERIES?

The FDA product code for DB PRECISION IMPLANT SYSTEM, 2000 SERIES is DZE.

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 Driskell Bioengineering 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.

K875243DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HACK875242DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HACK853788DB PRECISION IMPLANT SYSTEM

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

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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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