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FDA 510(k)

PS3 TITANIUM SCREW DENTAL IMPLANT

K-Number: K800762 · 1980-05-14

ApplicantColmed, Ltd.
Decision Date1980-05-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PS3 TITANIUM SCREW DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Colmed, Ltd.. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K800762. 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 PS3 TITANIUM SCREW DENTAL IMPLANT?

PS3 TITANIUM SCREW DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Colmed, Ltd.. The 510(k) number is K800762.

When did PS3 TITANIUM SCREW DENTAL IMPLANT receive FDA 510(k) clearance?

PS3 TITANIUM SCREW DENTAL IMPLANT received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800762.

Who is the listed applicant for PS3 TITANIUM SCREW DENTAL IMPLANT?

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

What is the FDA product code for PS3 TITANIUM SCREW DENTAL IMPLANT?

The FDA product code for PS3 TITANIUM SCREW DENTAL IMPLANT is DZE.

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Other records listing Colmed, Ltd. 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.

K811209JACOB WIRZ TRANSFIXATION PINK810636VARIODRAINK810117HALOGEN HEADLIGHT SYSTEMK801208HOLLOW BASKET TITANIUM DENTAL IMPLANTK801006CHARNLEY DESIGN HIP PROSTHESISK792241PELIMIT

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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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