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FDA 510(k)

ROOTFORM DENTAL IMPLANT SYSTEM

K-Number: K954758 · 1997-08-18

ApplicantSwiss Dental Center
Decision Date1997-08-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOTFORM DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Swiss Dental Center. It received FDA 510(k) clearance on 1997-08-18 under 510(k) number K954758. 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 ROOTFORM DENTAL IMPLANT SYSTEM?

ROOTFORM DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-18. The listed applicant is Swiss Dental Center. The 510(k) number is K954758.

When did ROOTFORM DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ROOTFORM DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1997-08-18, under 510(k) number K954758.

Who is the listed applicant for ROOTFORM DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for ROOTFORM DENTAL IMPLANT SYSTEM?

The FDA product code for ROOTFORM DENTAL IMPLANT SYSTEM 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

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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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