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FDA 510(k)

FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE

K-Number: K945847 · 1996-03-15

ApplicantFriatec Medical Inc., USA
Decision Date1996-03-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Friatec Medical Inc., USA. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K945847. 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 FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE?

FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Friatec Medical Inc., USA. The 510(k) number is K945847.

When did FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE receive FDA 510(k) clearance?

FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE received FDA 510(k) clearance on 1996-03-15, under 510(k) number K945847.

Who is the listed applicant for FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE?

The FDA 510(k) record lists Friatec Medical Inc., USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE?

The FDA product code for FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE is DZE.

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Other records listing Friatec Medical Inc., USA 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.

K945848FRIALIT(R)-2 DENTAL IMPLANTK945849FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATINGK934332SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES

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

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