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FDA 510(k)

TPS SCREW DENTAL IMPLANTS

K-Number: K843218 · 1984-09-27

ApplicantArtech Corp.
Decision Date1984-09-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TPS SCREW DENTAL IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Artech Corp.. It received FDA 510(k) clearance on 1984-09-27 under 510(k) number K843218. 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 TPS SCREW DENTAL IMPLANTS?

TPS SCREW DENTAL IMPLANTS is a medical device that received FDA 510(k) clearance on 1984-09-27. The listed applicant is Artech Corp.. The 510(k) number is K843218.

When did TPS SCREW DENTAL IMPLANTS receive FDA 510(k) clearance?

TPS SCREW DENTAL IMPLANTS received FDA 510(k) clearance on 1984-09-27, under 510(k) number K843218.

Who is the listed applicant for TPS SCREW DENTAL IMPLANTS?

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

What is the FDA product code for TPS SCREW DENTAL IMPLANTS?

The FDA product code for TPS SCREW DENTAL IMPLANTS is DZE.

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Other records listing Artech Corp. 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.

K911735ARTECH ARDENT IV - TYPE CLYLINDER IMPLANTK895267ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANTK891346ARTECH TYPE SS SUBMERGED SCREW IMPLANTK894160HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPLK894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTK894150COUNTERBORE FOR SS SUBMERGED SCREW PLANT

View all 8 devices →

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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