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FDA 510(k)

IMTEC BONE TAC

K-Number: K973180 · 1997-11-18

ApplicantImtec Corp.
Decision Date1997-11-18
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMTEC BONE TAC is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 1997-11-18 under 510(k) number K973180. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMTEC BONE TAC?

IMTEC BONE TAC is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is Imtec Corp.. The 510(k) number is K973180.

When did IMTEC BONE TAC receive FDA 510(k) clearance?

IMTEC BONE TAC received FDA 510(k) clearance on 1997-11-18, under 510(k) number K973180.

Who is the listed applicant for IMTEC BONE TAC?

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

What is the FDA product code for IMTEC BONE TAC?

The FDA product code for IMTEC BONE TAC is DZL.

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Other records listing Imtec 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.

K081653MDI MII ONE-PIECE IMPLANT, 2.9MMK081347ILUMA VISIONK072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114K053046ILUMA ORTHOCAT/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K042289MDI ORTHO

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Related Devices (Code: DZL)

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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

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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