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FDA 510(k)

STRAUMANN TIBRUSH

K-Number: K111724 · 2011-09-12

ApplicantStraumann USA
Decision Date2011-09-12
Product CodeELB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN TIBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2011-09-12 under 510(k) number K111724. 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 STRAUMANN TIBRUSH?

STRAUMANN TIBRUSH is a medical device that received FDA 510(k) clearance on 2011-09-12. The listed applicant is Straumann USA. The 510(k) number is K111724.

When did STRAUMANN TIBRUSH receive FDA 510(k) clearance?

STRAUMANN TIBRUSH received FDA 510(k) clearance on 2011-09-12, under 510(k) number K111724.

Who is the listed applicant for STRAUMANN TIBRUSH?

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

What is the FDA product code for STRAUMANN TIBRUSH?

The FDA product code for STRAUMANN TIBRUSH is ELB.

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Other records listing Straumann 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.

K151328PURE Ceramic ImplantsK130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSK130724CODIAGNOSTIX IMPLANT PLANNING SOFTWAREK122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSK121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMK113606NNC GOLD ABUTMENT FOR BRIDGES

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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.K121114TIGRAN PERIBRUSHTigran Technologies ABK003640MINIENDO 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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