MIRROR SHIELD— 510(k) K901053

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K901053 for MIRROR SHIELD, Substantially Equivalent on 1990-05-07. Applicant: Pulpdent Corp.. Device class: 1.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code EKJ
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1990-03-05
Decision date: 1990-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKJ

K961714 — ASEPTYLUM, UNI-CARRIER1996-06-10
K953707 — MEDTROL DENTAL KIT1996-01-04
K945815 — DENTAL KIT1995-07-19
K951607 — SUREFLEX FILES1995-06-22
K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL1994-11-30

More clearances from Pulpdent Corp.

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K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM2002-02-28
K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE2002-02-27
K013411 — PULPDENT CAVITY PREPARATION IV2001-12-12

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