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FDA 510(k)

ORTHOMITE 111 ADHESIVE

K-Number: K843527 · 1984-10-18

ApplicantRocky Mountain Orthodontics, Inc.
Decision Date1984-10-18
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOMITE 111 ADHESIVE 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 1984-10-18 under 510(k) number K843527. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOMITE 111 ADHESIVE?

ORTHOMITE 111 ADHESIVE is a medical device that received FDA 510(k) clearance on 1984-10-18. The listed applicant is Rocky Mountain Orthodontics, Inc.. The 510(k) number is K843527.

When did ORTHOMITE 111 ADHESIVE receive FDA 510(k) clearance?

ORTHOMITE 111 ADHESIVE received FDA 510(k) clearance on 1984-10-18, under 510(k) number K843527.

Who is the listed applicant for ORTHOMITE 111 ADHESIVE?

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 ORTHOMITE 111 ADHESIVE?

The FDA product code for ORTHOMITE 111 ADHESIVE is DYH.

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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 SYSTEMK780678IMPRESSION TRAYK780334ADHESIVE, BRACKET AND CONDITIONER RESINK780170ORTHODONTIC BRACKET PADSK780205ORTHODONTIC BUCCAL TUBE

Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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