ENDO-PREP— 510(k) K896663

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K896663 for ENDO-PREP, Substantially Equivalent on 1990-02-14. Applicant: Pulpdent Corp.. Device class: 1.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1989-11-24
Decision date: 1990-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKM

K073369 — EI DOWNPAK BARRIER SLEEVES2008-02-27
K070246 — DOWN PAK2007-02-16
K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)2006-06-26
K042870 — ENDO TWINN2005-01-11
K023819 — FIBERFILL SGP2003-03-26

More clearances from Pulpdent Corp.

K014133 — PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE2002-03-14
K014138 — PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT2002-03-14
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.