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FDA 510(k)

TOOTHBRUSH, ORTHODONTIC, #0126-0189-00

K-Number: K771184 · 1977-07-15

ApplicantHoyt Laboratories
Decision Date1977-07-15
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 is the device name listed in this FDA 510(k) record. The listed applicant is Hoyt Laboratories. It received FDA 510(k) clearance on 1977-07-15 under 510(k) number K771184. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOOTHBRUSH, ORTHODONTIC, #0126-0189-00?

TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is Hoyt Laboratories. The 510(k) number is K771184.

When did TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 receive FDA 510(k) clearance?

TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771184.

Who is the listed applicant for TOOTHBRUSH, ORTHODONTIC, #0126-0189-00?

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

What is the FDA product code for TOOTHBRUSH, ORTHODONTIC, #0126-0189-00?

The FDA product code for TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 is EFW.

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Other records listing Hoyt Laboratories 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.

K820738LUSTRALLOYK811154HOYT ECONO-TRAYK810830HOYT COTTON ROLLSK780834PREVI DENT PROPHYLAXIS MINT NDCK771881REPLICA BONDING AGENTK771880REPLICA DENTAL COMPOSIT

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Related Devices (Code: EFW)

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.

K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.K121165BEAM BRUSH/BEAM APPBeam Technologies, LLCK102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & GambleK021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLCK020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC

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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