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FDA 510(k)

ORTHODONTIC BUCCAL TUBE

K-Number: K780205 · 1978-02-16

ApplicantRocky Mountain Orthodontics, Inc.
Decision Date1978-02-16
Product CodeDZD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC BUCCAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Rocky Mountain Orthodontics, Inc.. It received FDA 510(k) clearance on 1978-02-16 under 510(k) number K780205. The device is classified under product code DZD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC BUCCAL TUBE?

ORTHODONTIC BUCCAL TUBE is a medical device that received FDA 510(k) clearance on 1978-02-16. The listed applicant is Rocky Mountain Orthodontics, Inc.. The 510(k) number is K780205.

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

ORTHODONTIC BUCCAL TUBE received FDA 510(k) clearance on 1978-02-16, under 510(k) number K780205.

Who is the listed applicant for ORTHODONTIC BUCCAL TUBE?

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

What is the FDA product code for ORTHODONTIC BUCCAL TUBE?

The FDA product code for ORTHODONTIC BUCCAL TUBE is DZD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rocky Mountain 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.

K895401NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEMK843527ORTHOMITE 111 ADHESIVEK780678IMPRESSION TRAYK780334ADHESIVE, BRACKET AND CONDITIONER RESINK780170ORTHODONTIC BRACKET PADS

Related Devices (Code: DZD)

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.

K943421ORTHODONITC ELASTOMERIC SLEEVINGJon-Ko Products, Inc.K936243REGENCY TUBEOrtho SpecialtiesK935143DENTAURUM STAINLESS STEEL TUBINGDentauraum, Inc.K911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)Aequitron Medical, Inc.K896586RATE INCREASE FOR IPPB/IPVPercussionaire Corp.K834446ALEXOTEK LINGUAL TUBESAlexotek 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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