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	OBL4514D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20102-16	FDA UDI	Class II	Active
KJ Submerged System	ITX-4008H	FDA UDI	Class II	Active
Kerator	G405	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL4002	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4513R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S0HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S3HB	FDA UDI	Class II	Active
J2E Implant System	CR501070NH	FDA UDI	Class II	Active
Kerator Metal Housing	CDP2	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA607020R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD26065S	FDA UDI	Class II	Active
J2R Implant System	JRIC6T1-CT	FDA UDI	Class I	Active
KJ Mini Implant System	MIBR4013-25D	FDA UDI	Class II	Active
J2R Implant System	JRFDHPWS	FDA UDI	Class I	Active
J2A Dental Implant System	OTF4307R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20152-16	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S4HA	FDA UDI	Class II	Active
KJ Submerged System	ITX-3508	FDA UDI	Class II	Active
Kerator	SRS454	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA505540R	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404050R	FDA UDI	Class II	Active
KJ Submerged System	ITX-5014	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254013H	FDA UDI	Class II	Active
KJ Submerged System	ITX-4012	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S1	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2016-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2016-18	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4010	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR60010A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S1HB	FDA UDI	Class II	Active
Kerator	T401	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5507RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3510-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S3HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S4HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS5004	FDA UDI	Class II	Active
J2I Implant System	JIF41115	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5010-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4011D	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA305013H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305011P	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5015-25	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD34065S	FDA UDI	Class II	Active
J2E Implant System	JEF3312S	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS600100	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305513P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S2HA	FDA UDI	Class II	Active
Kerator	BC306	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA24010S	FDA UDI	Class II	Active

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