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 Mini Implant System	MIPS4508-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2014-18	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA505530R	FDA UDI	Class II	Active
J2E Implant System	CM401070NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2014-18	FDA UDI	Class II	Active
J2R Implant System	JRICRT1-OT	FDA UDI	Class I	Active
Kerator	PA450	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2510-18	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS5010	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4513-25	FDA UDI	Class II	Active
Kerator	B405	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S0HA	FDA UDI	Class II	Active
Kerator	PA453	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S0HA	FDA UDI	Class II	Active
KERATOR Torque Tip	KMD61	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S2HB	FDA UDI	Class II	Active
KJ Submerged System	ITX-4512	FDA UDI	Class II	Active
J2R Implant System	JRF6011	FDA UDI	Class II	Active
J2R Implant System	JRANALW	FDA UDI	Class I	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA25050S	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC37560S	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS5515	FDA UDI	Class II	Active
J2E Implant System	CR601040NH	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30508S4	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S1HA	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA23565S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4510-25	FDA UDI	Class II	Active
J2E Implant System	JEF4008S	FDA UDI	Class II	Active
Kerator	AS352	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30508S3	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S1HB	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZMA-N	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454020R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB23566S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4514-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S0	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S3HB	FDA UDI	Class II	Active
KJ Submerged System	ITX-3509	FDA UDI	Class II	Active
J2E Implant System	JEF5014S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S1	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5014-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIA40010A15	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4515	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS3410	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5011R	FDA UDI	Class II	Active
Kerator Abutment	AT307	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2015-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3514-18	FDA UDI	Class II	Active
J2E Implant System	CR604055H	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3012-18	FDA UDI	Class II	Active

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