PY-CO-PROX TM DENTAL BRUSH— 510(k) K800831

Name: FDA 510(k) clearance K800831
Creator: U.S. Food and Drug Administration
Published: 1980-05-08

Substantially Equivalent

Block Drug Company, Inc.

FDA 510(k) clearance K800831 for PY-CO-PROX TM DENTAL BRUSH, Substantially Equivalent on 1980-05-08. Applicant: Block Drug Company, Inc.. Device class: 1.

Clearance details

Applicant: Block Drug Company, Inc.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1980-04-14
Decision date: 1980-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17

More clearances from Block Drug Company, Inc.

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K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM1994-12-20
K935925 — VISION PROPHY PASTE WITH FLUORIDE1994-01-26
K933893 — VISION PROPHY PASTE WITHOUT FLUORIDE1993-11-16
K884533 — SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM1989-04-12
K881974 — PROFICIENT(TM) PROPHYLAXIS ANGLE1988-07-25

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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