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	LTSA25408S3HA	FDA UDI	Class II	Active
KJ Mask	KM 102-S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2508-18	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404030M	FDA UDI	Class II	Active
KJ Mini Implant System	OBL5010	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454050M	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4516-25	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF6085RP	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA305510H	FDA UDI	Class II	Active
KJ Mini Implant System	OBL2511	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA306014P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA307013P	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB2061S	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS450130	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD36550S	FDA UDI	Class II	Active
KJ Mini Implant System	OBL5015	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF375085	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5515R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4511-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4005A25	FDA UDI	Class II	Active
J2E Implant System	CR603040NH	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB54066S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA307014P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S4HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA304512P	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3015-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4008-25	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3510	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4511-25	FDA UDI	Class II	Active
KJ Submerged System	ITX-4008	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD35050S	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4505A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2512-18	FDA UDI	Class II	Active
J2E Implant System	CW604040H	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR34010A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR5014-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S3	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5511R	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR50010A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIA34010A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR5008-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S4HB	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA304510H	FDA UDI	Class II	Active
KJ Submerged System	ITX-3510H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3512-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4505A25	FDA UDI	Class II	Active
J2E Implant System	JEF3318S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3011-18	FDA UDI	Class II	Active

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