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510(k) K841011

ELEVATOR - VARIOUS by Premier Dental Products Co. — Product Code EMS

K841011 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "ELEVATOR - VARIOUS". The FDA issued a decision of Substantially Equivalent on June 15, 1984. The device falls under product code EMS (Curette, Periodontic), a Class I device regulated under 21 CFR 872.4565. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1984
Date Received
March 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Periodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Premier Dental Products Co.

  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite (December 6, 2022)
  • K141839 — PREMIER ETCH (November 17, 2014)
  • K132526 — KNIT-PAK+ (November 26, 2013)
  • K131212 — PREMIER CERAMIC PRIMER (August 26, 2013)
  • K083695 — TRAXODENT (April 28, 2009)
  • K062683 — ENAMEL PRO VARNISH (November 21, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K061998 — PREMIER SELF-ETCHING BOND ENHANCER (October 4, 2006)

Other clearances for product code EMS

  • K931329 — DENTAL INSTRUMENTS CURETTE PERIODONTAL (January 27, 1994)
  • K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER) (July 31, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)
  • K834072 — INSTRUMENT, DENTAL (February 21, 1984)
  • K823319 — DENTAL INSTRUMENTS - SCALERS (November 24, 1982)
  • K821789 — BEACH CURETTE NO. 2 AND NO. 3 T.G. (July 6, 1982)

FDA data resources