TOOTHBRUSH, PEDODONTIC, #0126-0188-00— 510(k) K771183

Name: FDA 510(k) clearance K771183
Creator: U.S. Food and Drug Administration
Published: 1977-07-15

Substantially Equivalent

Hoyt Laboratories

FDA 510(k) clearance K771183 for TOOTHBRUSH, PEDODONTIC, #0126-0188-00, Substantially Equivalent on 1977-07-15. Applicant: Hoyt Laboratories. Device class: 1.

Clearance details

Applicant: Hoyt Laboratories
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1977-06-29
Decision date: 1977-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH2011-10-03
K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17

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K820738 — LUSTRALLOY1982-04-09
K811154 — HOYT ECONO-TRAY1981-05-13
K810830 — HOYT COTTON ROLLS1981-04-14
K780834 — PREVI DENT PROPHYLAXIS MINT NDC1978-06-02
K771881 — REPLICA BONDING AGENT1977-11-09

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.