FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

HYGIENIC ANCHORINGS

K Number: K780804 · Decision Jun 14, 1978
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
24
Applicant Total
6
Review Days
34

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Basic Information

Device Name
HYGIENIC ANCHORINGS
K Number
K780804
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.5410
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Hygienic Dental Mfg., Co., The
Date Received
May 11, 1978
Decision Date
June 14, 1978
Product Code
ECI
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
ECI Band, Elastic, Orthodontic

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Other Clearances by Hygienic Dental Mfg., Co., The

K Number Device Name
K780745 RUBBER DAM
K780743 CLAMP FORCEPS
K780746 HYGIENIC RUBBER DAM FRAME
K780744 BRINKER TISSUE RETRACTORS
K770117 HYGIENIC 5 & 6 RUBBER DAM FRAME