NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE— 510(k) K102769

Name: FDA 510(k) clearance K102769
Creator: U.S. Food and Drug Administration
Published: 2011-02-23

Substantially Equivalent

Jjgc Industria E Comercio DE Materiais Dentarios S

FDA 510(k) clearance K102769 for NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE, Substantially Equivalent on 2011-02-23. Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S. Device class: 2.

Clearance details

Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2010-09-24
Decision date: 2011-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAT

view all

K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck2026-05-19
K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device)2025-06-19
K231502 — Mini Screws2024-09-04
K231913 — T-FIT2024-02-08
K222245 — ACR Screw System2023-08-21

More clearances from Jjgc Industria E Comercio DE Materiais Dentarios S

view all

K153624 — Neodent Implant System2016-04-15
K141777 — NEODENT IMPLANT SYSTEM2015-07-20
K150367 — Neodent Implant System2015-07-13
K150199 — Neodent Implant System2015-06-15
K150182 — Neodent Implant System- CM Drive Implants2015-04-23

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.