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	MIBR5011-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4511D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S1HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3516-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3514	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA604020R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC25010S	FDA UDI	Class II	Active
KJ Mini Implant System	OBL5016D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S0HB	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3508	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404010M	FDA UDI	Class II	Active
J2E Implant System	JEF6010S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S4HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR5008A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3014-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5010	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4008	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3012-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4513-25D	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA705540R	FDA UDI	Class II	Active
J2E Implant System	CW604055H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S0	FDA UDI	Class II	Active
Kerator	SRS355	FDA UDI	Class II	Active
KJ Submerged System	ITX-5008H	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5016	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4005A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4511-25	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB25080S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S0HA	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF450085	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BTD3516	FDA UDI	Class I	Active
J2C SLA Dental Implant System	MTF4507RP	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457030M	FDA UDI	Class II	Active
KJ Submerged System	ITX-4508H	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3515	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4015-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S0HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S2	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405550M	FDA UDI	Class II	Active
J2A Dental Implant System	OTF3713M	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4511R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2516-18	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457020M	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30509S3	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4014-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBL2516	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30659S3	FDA UDI	Class II	Active
Kerator Abutment	AO407	FDA UDI	Class II	Active
Kerator	B506	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S1	FDA UDI	Class II	Active

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