Certain BellaTek Express and BellaTek Flex Abutments

Q: What is the product code of K183138?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.

FDA 510(k) K183138 · Biomet 3i

Substantially Equivalent

510(k) numberK183138

Submission

Device name: Certain BellaTek Express and BellaTek Flex Abutments
Applicant: Biomet 3i
Palm Beach Gardens, FL, US
Received: November 13, 2018
Decision date: July 2, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NHA – Abutment, Implant, Dental, Endosseous
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3630
Specialty: Dental
Implant: Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other 510(k)s with product code NHA

510(k)	Device	Applicant	Decision
K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional	Nobel Biocare AB	08/06/2026SE
K261147	Neodent Implant System - NeoConvert FitNHA · Traditional	JJGC Indústria e Comércio de Materiais Dentários…	07/01/2026SE
K261122	Mist IcNHA · Traditional	Imagine Milling Technologies, LLC	06/27/2026SE
K260061	BioHorizons CEREC Compatible Ti-BasesNHA · Traditional	BioHorizons Implant Systems, Inc.	06/26/2026SE
K253922	Neodent Scannable Healing AbutmentNHA · Traditional	JJGC Indústria e Comércio de Materiais Dentários…	06/15/2026SE
K254145	Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)NHA · Abbreviated	Smart Denture Conversions, LLC	06/11/2026SE
K260564	DESS Dental Smart SolutionsNHA · Traditional	Terrats Medical SL	06/09/2026SE
K252904	SIC Abutments including CAD/CAM SolutionsNHA · Traditional	Sic Invent AG	06/03/2026SE
K253774	Elos Accurate® Denture Fixation SystemNHA · Traditional	Elos Medtech Pinol A/S	05/20/2026SE
K253372	ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional	Hiossen, Inc.	05/14/2026SE

More from Hiossen, Inc.

510(k)	Device	Decision
K251660	T3 Pro Implants ZimVie Packaging SystemDZE · Special	06/27/2025SE
K241753	Immediate Molar ImplantsDZE · Traditional	10/23/2024SE
K241032	BellaTek BarsNHA · Traditional	07/15/2024SE
K220978	TSX ImplantsDZE · Traditional	09/14/2022SE
K213672	T3 Pro ImplantsDZE · Traditional	03/28/2022SE
K212730	BellaTek Encode Emergence Healing AbutmentsNHA · Special	12/21/2021SE
K192522	TSV BellaTek Express and BellaTek Flex AbutmentsNHA · Traditional	12/09/2019SE
K173374	TSV BellaTek Encode Healing AbutmentsNHA · Traditional	12/13/2017SE
K170013	Eztetic BellaTek Encode Healing AbutmentsNHA · Traditional	09/21/2017SE
K150571	3i T3 Short ImplantsDZE · Traditional	11/20/2015SE

Questions and answers

When was Certain BellaTek Express and BellaTek Flex Abutments cleared by the FDA?

Certain BellaTek Express and BellaTek Flex Abutments (K183138) received a 510(k) decision of Substantially Equivalent on July 2, 2019, 231 days after the submission was received.

What is the product code of K183138?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.