NNC GOLD ABUTMENT FOR BRIDGES— 510(k) K113606

Name: FDA 510(k) clearance K113606
Creator: U.S. Food and Drug Administration
Published: 2012-01-27

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K113606 for NNC GOLD ABUTMENT FOR BRIDGES, Substantially Equivalent on 2012-01-27. Applicant: Straumann USA. Device class: 2.

Clearance details

Applicant: Straumann USA
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2011-12-06
Decision date: 2012-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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 Straumann USA

view all

K151328 — PURE Ceramic Implants2016-01-11
K130724 — CODIAGNOSTIX IMPLANT PLANNING SOFTWARE2013-06-28
K130808 — STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS2013-06-28
K122855 — TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS2012-12-12
K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM2012-06-06

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.