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	MAF500115	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2508-18	FDA UDI	Class II	Active
J2E Implant System	JECSW	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BIST25	FDA UDI	Class I	Active
J2C SLA Dental Implant System	MTF6015RP	FDA UDI	Class II	Active
J2E Implant System	CR504055H	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4511-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S0	FDA UDI	Class II	Active
J2R Implant System	ESTHAN1	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4515RP	FDA UDI	Class II	Active
KJ Mini Implant System	OBM2515	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5012-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2516-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5505A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S0HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S1	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254510H	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2510-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3508-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIA55010A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20112-16	FDA UDI	Class II	Active
J2R Implant System	JRICRT2-CT	FDA UDI	Class I	Active
Hero 2 & IS Dental Implant System	MAF400130	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3516-25	FDA UDI	Class II	Active
J2R Implant System	JRANALR	FDA UDI	Class I	Active
J2C SLA Dental Implant System	MTF4315RP	FDA UDI	Class II	Active
J2R Implant System	JRF4311	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S3HB	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC35065S	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS5005	FDA UDI	Class II	Active
J2E Implant System	CR604070NH	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5511RP	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5015R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20111-16	FDA UDI	Class II	Active
KJ Mini Implant System	MIA6005A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3012-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4010D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S3HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S0	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA607010R	FDA UDI	Class II	Active
J2E Implant System	JEF3808S	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5515RP	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF375130	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4515-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR5015-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S2HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S3	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30659S2	FDA UDI	Class II	Active
Kerator Abutment	AT301	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD25050S	FDA UDI	Class II	Active

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