FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

NEUTROCIM

K Number: K771114 · Decision Jan 4, 1978
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
495
Applicant Total
11
Review Days
197

Basic Information

Device Name
NEUTROCIM
K Number
K771114
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3275
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
SEPTODONT, INC.
Date Received
June 21, 1977
Decision Date
January 4, 1978
Product Code
EMA
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
EMA Cement, Dental

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Other Clearances by SEPTODONT, INC.

K Number Device Name
K780003 ENDOSOLV E
K761354 CIMPAT (PINK AND WHITE)
K761355 SELFAST
K760798 FLUOCAL GEL MINT
K760799 FLUOCAL GEL ORANGE
K761024 RACESTYPTINE RINGS
K760660 HYDROL
K760659 CALCIPULPE
K760658 DETARTRINE P
K760657 RACESTYPTINE CORD
Search all 11 clearances from SEPTODONT, INC. →