4plus6Line Abutment System— 510(k) K151608

Name: FDA 510(k) clearance K151608
Creator: U.S. Food and Drug Administration
Published: 2016-04-13

Substantially Equivalent

Ot Medical GmbH

FDA 510(k) clearance K151608 for 4plus6Line Abutment System, Substantially Equivalent on 2016-04-13. Applicant: Ot Medical GmbH. Device class: 2.

Clearance details

Applicant: Ot Medical GmbH
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2015-06-15
Decision date: 2016-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHA

view all

K253999 — Universal Base ASC Engaging +6 more2026-08-06
K261147 — Neodent Implant System - NeoConvert Fit2026-07-01
K261122 — MIST IC2026-06-27
K260061 — BioHorizons CEREC Compatible Ti-Bases2026-06-26
K253922 — Neodent Scannable Healing Abutment2026-06-15

More clearances from Ot Medical GmbH

view all

K151432 — NaturalLine Abutment2015-11-05
K113113 — ENDOSSEOUS DENTAL IMPLANT2012-11-16

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.