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
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S3	FDA UDI	Class II	Active
J2R Implant System	JRC6N	FDA UDI	Class II	Active
Kerator Cap	CPP2	FDA UDI	Class II	Active
Kerator Abutment	AO402	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203511P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S2HA	FDA UDI	Class II	Active
KJ Submerged System	ITX-4511	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4005A25	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457020R	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457010R	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA306010H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S1HB	FDA UDI	Class II	Active
J2E Implant System	CR504040NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20113-16	FDA UDI	Class II	Active
Kerator Abutment	AT405	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS450100	FDA UDI	Class II	Active
J2A Dental Implant System	OTF3710M	FDA UDI	Class II	Active
Kerator	G400	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S2	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20141-16	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4016	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S2HA	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3010	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2010-18	FDA UDI	Class II	Active
Kerator	B333	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR45010A25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA304511H	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4508D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3510-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL5003	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307008H	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4015-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA307012P	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4510	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3011-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S1HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S3HB	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA607010R	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5011R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30506S1HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S2HA	FDA UDI	Class II	Active
KJ Submerged System	ITX-4514H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S2HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S0HB	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF410115	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB24065S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S2HB	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4011RP	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS450073	FDA UDI	Class II	Active

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