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FDA 510(k)

ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY

K-Number: K863028 · 1986-10-06

ApplicantRoss Implant Technologies Corp., Inc.
Decision Date1986-10-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Ross Implant Technologies Corp., Inc.. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K863028. 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 ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY?

ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is Ross Implant Technologies Corp., Inc.. The 510(k) number is K863028.

When did ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY receive FDA 510(k) clearance?

ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY received FDA 510(k) clearance on 1986-10-06, under 510(k) number K863028.

Who is the listed applicant for ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY?

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

What is the FDA product code for ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY?

The FDA product code for ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY 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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