POLYCARBONATE TEMPORARY CEMENT— 510(k) K802662

Name: FDA 510(k) clearance K802662
Creator: U.S. Food and Drug Administration
Published: 1980-12-16

Substantially Equivalent

Buffalo Dental Mfg. Co., Inc.

FDA 510(k) clearance K802662 for POLYCARBONATE TEMPORARY CEMENT, Substantially Equivalent on 1980-12-16. Applicant: Buffalo Dental Mfg. Co., Inc.. Device class: 2.

Clearance details

Applicant: Buffalo Dental Mfg. Co., Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1980-10-28
Decision date: 1980-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

view all

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Buffalo Dental Mfg. Co., Inc.

view all

K955573 — OPTIBLAST INTRAORAL SANDBLASTER1996-05-03
K945220 — AMALGAM CARRIER1995-01-11
K941954 — NON-FOGGING DENTAL MIRROR1994-07-08
K841491 — CONVENTIONAL PLASTIC DENTAL TRAYS1984-07-13
K841323 — FUZZY TRAY1984-06-27

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