PULPDENT DENTAL BOND ENHANCER 2-B— 510(k) K931710

Name: FDA 510(k) clearance K931710
Creator: U.S. Food and Drug Administration
Published: 1993-08-24

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K931710 for PULPDENT DENTAL BOND ENHANCER 2-B, Substantially Equivalent on 1993-08-24. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1993-04-06
Decision date: 1993-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Pulpdent Corp.

view all

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.