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	LTSA20509S3HA	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457040M	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA705550R	FDA UDI	Class II	Active
Kerator	SRS455	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S4HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S2	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA25065S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4512-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2514-18	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5011RP	FDA UDI	Class II	Active
Kerator Abutment	AR406	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB36565S	FDA UDI	Class II	Active
KJ Submerged System	ITX-5012	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR6008A15	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307010H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	DSR100	FDA UDI	Class I	Active
J2R Implant System	JRHA6605	FDA UDI	Class II	Active
Kerator	SRS505	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4010R	FDA UDI	Class II	Active
J2R Implant System	JRTA6-E	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL3403	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA304509P	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA605550R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S1	FDA UDI	Class II	Active
J2R Implant System	JRHAW603	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254011P	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA505510R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA204014P	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3510-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4508A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4010-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S0	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4510-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3516-25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254512H	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457050M	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2010-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2008-18	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB23564S	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA457040M	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5515R	FDA UDI	Class II	Active
Kerator	SRS356	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS4503	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5015RP	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5585R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203510P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30506S2	FDA UDI	Class II	Active
Kerator Abutment	AO403	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL3404	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S4	FDA UDI	Class II	Active

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