ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION— 510(k) K112730

Clearance details

Applicant

Biomet 3i

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2011-09-20

Decision date

2012-01-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Palm Beach Gardens, FL, US

• 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

• K183138 — Certain BellaTek Express and BellaTek Flex Abutments2019-07-02
• K173374 — TSV BellaTek Encode Healing Abutments2017-12-13
• K170013 — Eztetic BellaTek Encode Healing Abutments2017-09-21
• K150571 — 3i T3 Short Implants2015-11-20
• K133049 — 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS2014-01-08

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 →

• Z-2422-2016 — LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implantsClass II·Terminated·Biomet 3i, LLC·20151125
• Z-2423-2016 — LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implantsClass II·Terminated·Biomet 3i, LLC·20151125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112730.