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FDA 510(k)

ORTHODONTIC BRACKET PADS

K-Number: K780170 · 1978-03-15

ApplicantRocky Mountain Orthodontics, Inc.
Decision Date1978-03-15
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC BRACKET PADS 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 1978-03-15 under 510(k) number K780170. 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 ORTHODONTIC BRACKET PADS?

ORTHODONTIC BRACKET PADS is a medical device that received FDA 510(k) clearance on 1978-03-15. The listed applicant is Rocky Mountain Orthodontics, Inc.. The 510(k) number is K780170.

When did ORTHODONTIC BRACKET PADS receive FDA 510(k) clearance?

ORTHODONTIC BRACKET PADS received FDA 510(k) clearance on 1978-03-15, under 510(k) number K780170.

Who is the listed applicant for ORTHODONTIC BRACKET PADS?

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 BRACKET PADS?

The FDA product code for ORTHODONTIC BRACKET PADS is EJF.

Related Clinical Trials

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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 RESINK780205ORTHODONTIC BUCCAL TUBE

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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