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
Kerator	BC207	FDA UDI	Class II	Active
J2R Implant System	JRCRN	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS600115	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S4	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA604040R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S1HA	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254509H	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB35065S	FDA UDI	Class II	Active
KJ Submerged System	ITX-3510	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3012	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S3HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S2HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL4003	FDA UDI	Class II	Active
Kerator	BC304	FDA UDI	Class II	Active
Kerator	PA456	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS4002	FDA UDI	Class II	Active
KJ Mini Implant System	OBL3015	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4016-25	FDA UDI	Class II	Active
J2E Implant System	JEF3816S	FDA UDI	Class II	Active
J2R Implant System	JRF3513	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20143-16	FDA UDI	Class II	Active
J2I Implant System	ITPA6540	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203510H	FDA UDI	Class II	Active
Kerator Magic Tool	KMT002	FDA UDI	Class II	Active
Kerator	SRS354	FDA UDI	Class II	Active
J2I Implant System	ITPA6555	FDA UDI	Class II	Active
Kerator	CDPH2	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3511	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4516-25	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404010R	FDA UDI	Class II	Active
KJ Mini Implant System	MIA6005A25	FDA UDI	Class II	Active
KJ Submerged System	ITX-6014H	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA705510R	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5010RP	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB3061S	FDA UDI	Class II	Active
KJ Submerged System	ITX-6009	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS6008	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4516	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA204012H	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4015-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25509S4	FDA UDI	Class II	Active
J2A Dental Implant System	OTF6007R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254013P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S0HB	FDA UDI	Class II	Active
Kerator Abutment	AR405	FDA UDI	Class II	Active
Kerator	AS405	FDA UDI	Class II	Active
KJ Submerged System	ITX-5011	FDA UDI	Class II	Active
KJ Mini Implant System	OBL2513	FDA UDI	Class II	Active

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