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FDA 510(k)

ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT

K-Number: K895267 · 1990-04-10

ApplicantArtech Corp.
Decision Date1990-04-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Artech Corp.. It received FDA 510(k) clearance on 1990-04-10 under 510(k) number K895267. 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 ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT?

ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT is a medical device that received FDA 510(k) clearance on 1990-04-10. The listed applicant is Artech Corp.. The 510(k) number is K895267.

When did ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT receive FDA 510(k) clearance?

ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT received FDA 510(k) clearance on 1990-04-10, under 510(k) number K895267.

Who is the listed applicant for ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT?

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 ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT?

The FDA product code for ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT 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 IMPLANTK891346ARTECH TYPE SS SUBMERGED SCREW IMPLANTK894160HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPLK894151IRRIGATED 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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