Question 1

What types of medical devices does Kj Meditech manufacture?

Accepted Answer

Kj Meditech specializes in dental and orthodontic devices. Their portfolio includes dental implant components such as permanent and temporary preformed suprastructures, one-piece and two-piece screw endosteal implants, and full dental implant systems. They also produce orthodontic tools like anchoring screws and extraoral headgear, as well as dental implant analogs for laboratory use. These devices are designed for dental restoration, orthodontic treatment, and implantology.

Question 2

Where is Kj Meditech based, and what regulatory database lists its devices?

Accepted Answer

Kj Meditech is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a publicly accessible registry tracking medical devices authorized for use in the U.S. This database helps ensure transparency and traceability of their products under FDA regulations.

Question 3

How are Kj Meditech’s devices classified under FDA regulations?

Accepted Answer

Kj Meditech’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like dental implant analogs or minor orthodontic tools, while Class II covers moderate-risk items such as dental implant systems and suprastructures, which require special controls to ensure safety and effectiveness. The classification depends on factors like intended use, risk level, and regulatory history.

Question 4

What kinds of dental implant systems does Kj Meditech produce, and how do they differ?

Accepted Answer

Kj Meditech manufactures a range of dental implant systems, including one-piece and two-piece screw endosteal implants, which integrate directly into the jawbone. Their portfolio also includes systems with different surface treatments (e.g., SLA or HA), designed to improve osseointegration. Temporary and permanent preformed suprastructures are additional components, while submerged implant systems (like the KJ SUBMERGED SYSTEM) allow for controlled healing beneath the gumline. Modular abutments further enable customization for patient-specific restorations.

Device	Model / Reference	Registries	Class	Status
Hero 2 & IS Dental Implant System	MAF600160	FDA UDI	Class II	Active
Kerator Abutment	AO401	FDA UDI	Class II	Active
J2E Implant System	JEF5108S	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF410160	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3015-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5015-25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254014H	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4510R	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3008	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR3408A15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S0HA	FDA UDI	Class II	Active
J2A Dental Implant System	OTF6007R	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA306008H	FDA UDI	Class II	Active
Kerator	AS355	FDA UDI	Class II	Active
Kerator	AS402	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S2	FDA UDI	Class II	Active
J2E Implant System	JEF5008S	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4007RP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455540R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3014-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BTD3016	FDA UDI	Class I	Active
Two-Piece Type Abutments	TWA457020R	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA455540M	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404030R	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5014	FDA UDI	Class II	Active
KJ Mini Implant System	MIA3408A25	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457030R	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4508A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS5011-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2008-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4015D	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB26065S	FDA UDI	Class II	Active
J2R Implant System	JRF5016	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5513RP	FDA UDI	Class II	Active
Kerator	BC301	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD25010S	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS6005	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305509P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S3HA	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4013	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5008A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIA55010A15	FDA UDI	Class II	Active
Cover Screw	CVSR	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4007R	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3015	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454010M	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4012-25	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA504040R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3013-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S0	FDA UDI	Class II	Active

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