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EJE — Frame, Rubber Dam Class I

FDA Device Classification

FDA product code EJE covers "Frame, Rubber Dam", a Class I medical device regulated under 21 CFR 872.6300. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EJE
Device Class
Class I
Regulation Number
872.6300
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K781520young dental manufacturing co. 1RUBBER DAM HOLDEROctober 10, 1978
K780746hygienic dental mfg., co., theHYGIENIC RUBBER DAM FRAMEMay 12, 1978
K770117hygienic dental mfg., co., theHYGIENIC 5 & 6 RUBBER DAM FRAMEJanuary 28, 1977

FDA data resources