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	OBL4514	FDA UDI	Class II	Active
Kerator	PA352	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5011	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S2HA	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB54064S	FDA UDI	Class II	Active
KJ Submerged System	ITX-6008	FDA UDI	Class II	Active
J2I Implant System	ITPA6570	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4385R	FDA UDI	Class II	Active
J2E Implant System	CR504070H	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5507RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4512-25	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD36565S	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5005A20	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4513	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S0	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3012-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIA34010A20	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4315R	FDA UDI	Class II	Active
Kerator	G401	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA37560S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25508S3	FDA UDI	Class II	Active
J2E Implant System	CR503070H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S4HA	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA407050R	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5585RP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405510M	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4010-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3011-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S2	FDA UDI	Class II	Active
J2E Implant System	CR602070H	FDA UDI	Class II	Active
J2R Implant System	JRTAW-NE	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305508P	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4508-25	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS5011	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S3HB	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF470160	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR55010A15	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4514	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4513-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR40010A25	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4507R	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4014	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S2HB	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA504050R	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA407040R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20101-16	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4014-25D	FDA UDI	Class II	Active

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