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	MIASL5002	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454040M	FDA UDI	Class II	Active
Kerator	BC302	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3513-25	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA605510R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3512-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2013-18	FDA UDI	Class II	Active
J2E Implant System	CR504070NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS3408	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB35012S	FDA UDI	Class II	Active
KJ Submerged System	ITX-5010	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S3	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S3HA	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS5015	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4513RP	FDA UDI	Class II	Active
J2C Dental Implant System	MTF6010R	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS6015	FDA UDI	Class II	Active
KJ Mini Implant System	OBM2513	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3515-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S2HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25506S2	FDA UDI	Class II	Active
Kerator	B332	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS5012	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3513	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457010R	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4010R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB2041S	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF3707MP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA607040R	FDA UDI	Class II	Active
J2E Implant System	JEF4014S	FDA UDI	Class II	Active
Kerator	B337	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S4HB	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA507020R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S1HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S1HB	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457040R	FDA UDI	Class II	Active
KJ Mini Implant System	MIA6008A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S0	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4011-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S1HB	FDA UDI	Class II	Active
KJ Submerged System	ITX-4509	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS4504	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S1	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25659S3	FDA UDI	Class II	Active
KJ Submerged System	ITX-3512H	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1612	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5515RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4016-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25508S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254512P	FDA UDI	Class II	Active

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