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

ABSORBENT ENDODONTIC POINT

K Number: K843017 · Decision Jan 9, 1985
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
5
Review Days
162

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
ABSORBENT ENDODONTIC POINT
K Number
K843017
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3830
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
United Dental Mfg., Inc.
Date Received
July 31, 1984
Decision Date
January 9, 1985
Product Code
EKN
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
EKN Point, Paper, Endodontic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EKN), ordered by most recent decision date.

View all

Other Clearances by United Dental Mfg., Inc.

K Number Device Name
K823686 REAMER TYPE K ENDODONTIC
K823685 FILE TYPE H (HEDSTROEM) ENDODONTIC
K823684 FILE TYPE K ENDODONTIC
K812886 ENDODONTIC PAPER POINTS