BellaTek Encode Emergence Healing Abutments— 510(k) K212730

Name: FDA 510(k) clearance K212730
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Substantially Equivalent

Biomet 3i, LLC

FDA 510(k) clearance K212730 for BellaTek Encode Emergence Healing Abutments, Substantially Equivalent on 2021-12-21. Applicant: Biomet 3i, LLC. Device class: 2.

Clearance details

Applicant: Biomet 3i, LLC
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2021-08-30
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, 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 Biomet 3i, LLC

view all

K251660 — T3 Pro Implants ZimVie Packaging System2025-06-27
K241753 — Immediate Molar Implants2024-10-23
K241032 — BellaTek Bars2024-07-15
K220978 — TSX Implants2022-09-14
K213672 — T3 Pro Implants2022-03-28

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.