CEMENT, RESIN DENTAL (SOLO-TACH)

K760376 · L.D. Caulk Co. · DYH · Aug 23, 1976 · Dental

Device Facts

Record IDK760376
Device NameCEMENT, RESIN DENTAL (SOLO-TACH)
ApplicantL.D. Caulk Co.
Product CodeDYH · Dental
Decision DateAug 23, 1976
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3750
Device ClassClass 2

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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