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FDA 510(k)

TIGRAN PERIBRUSH

K-Number: K121114 · 2012-09-17

ApplicantTigran Technologies AB
Decision Date2012-09-17
Product CodeELB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIGRAN PERIBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Tigran Technologies AB. It received FDA 510(k) clearance on 2012-09-17 under 510(k) number K121114. The device is classified under product code ELB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIGRAN PERIBRUSH?

TIGRAN PERIBRUSH is a medical device that received FDA 510(k) clearance on 2012-09-17. The listed applicant is Tigran Technologies AB. The 510(k) number is K121114.

When did TIGRAN PERIBRUSH receive FDA 510(k) clearance?

TIGRAN PERIBRUSH received FDA 510(k) clearance on 2012-09-17, under 510(k) number K121114.

Who is the listed applicant for TIGRAN PERIBRUSH?

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

What is the FDA product code for TIGRAN PERIBRUSH?

The FDA product code for TIGRAN PERIBRUSH is ELB.

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Related Devices (Code: ELB)

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.

K170596TN-BrushGenoss Co., Ltd.K111724STRAUMANN TIBRUSHStraumann USAK003640MINIENDO IIISybron Dental Specialties, Inc.K831037AIR BURBINE HANDPIECE-DENTAL SCALINGTaco Dental, Inc.K782007ROTARY SCALERStar Dental Mfg. Co.

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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