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
KJ Submerged System	ITX-4509H	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS600130	FDA UDI	Class II	Active
Kerator	BC205	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF3711MP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455550M	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3008-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30509S4	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3508-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20151-16	FDA UDI	Class II	Active
J2E Implant System	CR601055NH	FDA UDI	Class II	Active
J2R Implant System	JRFDHP6L	FDA UDI	Class I	Active
Kerator	T402	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254014P	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5085R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD25010S	FDA UDI	Class II	Active
KJ Submerged System	ITX-5010H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S4	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S4HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S3	FDA UDI	Class II	Active
J2E Implant System	JEF5110S	FDA UDI	Class II	Active
J2R Implant System	EZAWPT2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA304513P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30506S3	FDA UDI	Class II	Active
J2E Implant System	CW702055NH	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254011H	FDA UDI	Class II	Active
J2E Implant System	CR501040NH	FDA UDI	Class II	Active
KJ Mini Implant System	OBL3508	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S0HA	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254010H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4508-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S1	FDA UDI	Class II	Active
J2R Implant System	JRFDHPRL	FDA UDI	Class I	Active
J2R Implant System	EZA6T1	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S3HA	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5015R	FDA UDI	Class II	Active
KJ Submerged System	ITX-4014	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5013RP	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BGP25	FDA UDI	Class I	Active
J2E Implant System	JEF5114S	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF500130	FDA UDI	Class II	Active
KJ Mini Implant System	MIA60010A15	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS500115	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF6011RP	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4007R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S0	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405550R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30506S3HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S4	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS4510	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4008A25	FDA UDI	Class II	Active

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