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FDA 510(k)

FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING

K-Number: K945849 · 1996-03-15

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

Device Summary

FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING 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 K945849. 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 CYLINDER WITH FRIOS(R) TI-COATING?

FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING 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 K945849.

When did FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING receive FDA 510(k) clearance?

FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING received FDA 510(k) clearance on 1996-03-15, under 510(k) number K945849.

Who is the listed applicant for FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING?

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 CYLINDER WITH FRIOS(R) TI-COATING?

The FDA product code for FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING 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 IMPLANTK945847FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACEK934332SURGICAL 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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