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
Kerator Abutment	AT305	FDA UDI	Class II	Active
J2I Implant System	ISA6555	FDA UDI	Class II	Active
J2R Implant System	JRHA6603	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BFD20H	FDA UDI	Class I	Active
J2R Implant System	JRF4316	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA505520R	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4013R	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4311RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5008A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4516-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S1HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4514-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S4HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIA6008A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3010-18	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5513R	FDA UDI	Class II	Active
Kerator	BC305	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3515-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3016-18	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA505550R	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4013	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA204014H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S1HB	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB2361S	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4511R	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA504010R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S2HB	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB25050S	FDA UDI	Class II	Active
Kerator	AS404	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4508	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA307011P	FDA UDI	Class II	Active
J2C Dental Implant System	MTF3715M	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF450100	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA604010R	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF500085	FDA UDI	Class II	Active
J2C Dental Implant System	MTF6013R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD23565S	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2011-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S4HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S1HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S1	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3008-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBL5016	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S3HB	FDA UDI	Class II	Active
J2R Implant System	JRICNT1-CT	FDA UDI	Class I	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB34065S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5010-25D	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL4010	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4313R	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA705520R	FDA UDI	Class II	Active

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