ENAMEL MICROABRASION COMPOUND— 510(k) K891536

Name: FDA 510(k) clearance K891536
Creator: U.S. Food and Drug Administration
Published: 1989-06-09

Substantially Equivalent

Premier Dental Products Co.

FDA 510(k) clearance K891536 for ENAMEL MICROABRASION COMPOUND, Substantially Equivalent on 1989-06-09. Applicant: Premier Dental Products Co.. Device class: 1.

Clearance details

Applicant: Premier Dental Products Co.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 1989-03-17
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJR

view all

K171189 — AIR-FLOW PLUS Prophylaxis powder2017-09-11
K131760 — WHIP MIX PREPPIES PLUS2014-03-26
K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN2012-08-06
K103114 — OSSPRAY SYLC CR2011-03-14
K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE2011-02-03

More clearances from Premier Dental Products Co.

view all

K141839 — PREMIER ETCH2014-11-17
K132526 — KNIT-PAK+2013-11-26
K131212 — PREMIER CERAMIC PRIMER2013-08-26
K083695 — TRAXODENT2009-04-28
K062166 — ENAMEL PRO2006-11-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.