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	OBL4511	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25509S3	FDA UDI	Class II	Active
KJ Submerged System	ITX-3512	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203509P	FDA UDI	Class II	Active
J2I Implant System	JIF48080	FDA UDI	Class II	Active
J2E Implant System	CM403070H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BIR25	FDA UDI	Class I	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S3	FDA UDI	Class II	Active
J2E Implant System	JEF4512S	FDA UDI	Class II	Active
J2R Implant System	JRF5013	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3511-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3510-18	FDA UDI	Class II	Active
J2R Implant System	JRF6013	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4011-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4012-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S2HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4012-25D	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4011	FDA UDI	Class II	Active
J2R Implant System	JRTAW-E	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4315R	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5505A15	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4010	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4011-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5010-25	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA605520R	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL4011	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S0HB	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405530R	FDA UDI	Class II	Active
Kerator	PA451	FDA UDI	Class II	Active
Kerator	PA452	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4513	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA604050R	FDA UDI	Class II	Active
Kerator	G402	FDA UDI	Class II	Active
KJ Submerged System	ITX-3511H	FDA UDI	Class II	Active
J2A Dental Implant System	OTF3785M	FDA UDI	Class II	Active
KJ Mini Implant System	OBL3510	FDA UDI	Class II	Active
Kerator	BC202	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5085RP	FDA UDI	Class II	Active
J2C Dental Implant System	MTF6015R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4512-25D	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254511H	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4011R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S1HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2008-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR60010A25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S3HA	FDA UDI	Class II	Active
KJ Submerged System	ITX-3511	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S0HA	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4012	FDA UDI	Class II	Active

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