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
J2A SLA Dental Implant System	OTF4511RP	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4508	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA306008P	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC35050S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S3	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305511P	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB2042S	FDA UDI	Class II	Active
KJ Mini Implant System	MIAA15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S0HB	FDA UDI	Class II	Active
J2A Dental Implant System	OTF6011R	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1412	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2516-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S2HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3513-25	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL4015	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S0	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL4014	FDA UDI	Class II	Active
J2E Implant System	JEF5012S	FDA UDI	Class II	Active
J2R Implant System	JRFDHP6S	FDA UDI	Class I	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BGP20	FDA UDI	Class I	Active
J2E Implant System	CW701055NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS4502	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3511-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS5015-25	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4307RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2013-18	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4385RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5014-25	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB24080S	FDA UDI	Class II	Active
KJ Submerged System	ITX-4011	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR40010A20	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254009H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S2HA	FDA UDI	Class II	Active
J2R Implant System	ESTHA61	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4516-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3511-25	FDA UDI	Class II	Active
Kerator	B401	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254008P	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4311RP	FDA UDI	Class II	Active
J2R Implant System	ESTHAR1	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF3711MP	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS400115	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC36580S	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA24080S	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4008	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5508A15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S3HA	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3511	FDA UDI	Class II	Active

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