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FDA 510(k)

BUCCAL TUBE, BUCCAL ATTACHMENT

K-Number: K904093 · 1990-11-07

ApplicantLancer Orthodontics, Inc.
Decision Date1990-11-07
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUCCAL TUBE, BUCCAL ATTACHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Lancer Orthodontics, Inc.. It received FDA 510(k) clearance on 1990-11-07 under 510(k) number K904093. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUCCAL TUBE, BUCCAL ATTACHMENT?

BUCCAL TUBE, BUCCAL ATTACHMENT is a medical device that received FDA 510(k) clearance on 1990-11-07. The listed applicant is Lancer Orthodontics, Inc.. The 510(k) number is K904093.

When did BUCCAL TUBE, BUCCAL ATTACHMENT receive FDA 510(k) clearance?

BUCCAL TUBE, BUCCAL ATTACHMENT received FDA 510(k) clearance on 1990-11-07, under 510(k) number K904093.

Who is the listed applicant for BUCCAL TUBE, BUCCAL ATTACHMENT?

The FDA 510(k) record lists Lancer Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUCCAL TUBE, BUCCAL ATTACHMENT?

The FDA product code for BUCCAL TUBE, BUCCAL ATTACHMENT is EJF.

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Other records listing Lancer Orthodontics, Inc. 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.

K122069STORM MINI SCREWK071192BLUGOO HDK051552O.A.S.I. SYSTEMK991481PARAGONK904090ORTHODONTIC BONDING ADHESIVE CONTROLK904092LANCER ORIGINAL, SIERRA, GENERAL PURPOSE

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Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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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