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	LTSA25509S1HB	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS600073	FDA UDI	Class II	Active
Kerator Abutment	AT404	FDA UDI	Class II	Active
Kerator Metal Cap	CP2	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS450085	FDA UDI	Class II	Active
Kerator	SRS456	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD26050S	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA455510M	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR5014-25D	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4012	FDA UDI	Class II	Active
KJ Submerged System	ITX-3514H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S0HB	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4385R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC24065S	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA507040R	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF470130	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4013RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2514-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIA50010A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S0HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S1	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA204011P	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC36550S	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3512	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S2	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA304508H	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA306012H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BGP30	FDA UDI	Class I	Active
KJ Mini Implant System	MIPR2010-18	FDA UDI	Class II	Active
Kerator	B407	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2016-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	ZBTD45	FDA UDI	Class I	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30506S3	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3508-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203508P	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4014	FDA UDI	Class II	Active
J2I Implant System	JIF48100	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3014	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4015RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4008A15	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF3710MP	FDA UDI	Class II	Active
J2R Implant System	JRF4310	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5008-25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA204011H	FDA UDI	Class II	Active
J2E Implant System	CR603040H	FDA UDI	Class II	Active
KJ Submerged System	ITX-4514	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4515-25	FDA UDI	Class II	Active
J2E Implant System	CR504055NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS4508	FDA UDI	Class II	Active

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