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FDA 510(k)

HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL

K-Number: K894160 · 1989-09-28

ApplicantArtech Corp.
Decision Date1989-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL is the device name listed in this FDA 510(k) record. The listed applicant is Artech Corp.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894160. 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 HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL?

HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Artech Corp.. The 510(k) number is K894160.

When did HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL receive FDA 510(k) clearance?

HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894160.

Who is the listed applicant for HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL?

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 HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL?

The FDA product code for HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL 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 IMPLANTK894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTK894150COUNTERBORE FOR SS SUBMERGED SCREW PLANTK843217HOLLOW BASKET DENTAL IMPLANTS

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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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