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FDA 510(k)

SELF TAPPING DENTAL IMPLANT SYSTEM

K-Number: K933532 · 1994-09-21

ApplicantImplant Support Systems, Inc.
Decision Date1994-09-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF TAPPING DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implant Support Systems, Inc.. It received FDA 510(k) clearance on 1994-09-21 under 510(k) number K933532. 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 SELF TAPPING DENTAL IMPLANT SYSTEM?

SELF TAPPING DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Implant Support Systems, Inc.. The 510(k) number is K933532.

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

SELF TAPPING DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1994-09-21, under 510(k) number K933532.

Who is the listed applicant for SELF TAPPING DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for SELF TAPPING DENTAL IMPLANT SYSTEM?

The FDA product code for SELF TAPPING DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Implant Support Systems, Inc. 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.

K924589RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMK925312HAND INSTRUMENT CALCULUS REMOVALK925313TITANIUM COC ABUTMENT HEADS FOR IMZK925349ONE SYSTEM TAPERED TITANIUM ABUTMENTSK924190ISS O-RING ATTACHMENTK921764DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS

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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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