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FDA 510(k)

FRIALIT -2 SCREW

K-Number: K974358 · 1998-02-10

ApplicantFriatec AG
Decision Date1998-02-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRIALIT -2 SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Friatec AG. It received FDA 510(k) clearance on 1998-02-10 under 510(k) number K974358. 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 -2 SCREW?

FRIALIT -2 SCREW is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Friatec AG. The 510(k) number is K974358.

When did FRIALIT -2 SCREW receive FDA 510(k) clearance?

FRIALIT -2 SCREW received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974358.

Who is the listed applicant for FRIALIT -2 SCREW?

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

What is the FDA product code for FRIALIT -2 SCREW?

The FDA product code for FRIALIT -2 SCREW is DZE.

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Other records listing Friatec AG 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.

K982576FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476K980630FRIALIT-2 CORABASEK973924FRIOS BONESHIELDK974628FRIALIT-2 PROTECT ABUTMENTK974359FRIALIT-2 CYLINDER

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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