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
Two-Piece Type Abutments	TWA607020R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S4	FDA UDI	Class II	Active
J2I Implant System	JIF43115	FDA UDI	Class II	Active
Kerator	B406	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1606	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR34010A15	FDA UDI	Class II	Active
Kerator	T404	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4510RP	FDA UDI	Class II	Active
KJ Mini Implant System	OBM2514	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S1HA	FDA UDI	Class II	Active
Kerator	B507	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S3HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4013-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3516-18	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF6007RP	FDA UDI	Class II	Active
J2A Dental Implant System	OTF3715M	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4011-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2515-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S3	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD25065S	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA305009H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA306010P	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1408	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3515-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS5510	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254510P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	DSR080	FDA UDI	Class I	Active
KJ Mini Implant System	MIBS2012-18	FDA UDI	Class II	Active
J2E Implant System	CW704055H	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF375115	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF400115	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL4503	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20162-16	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF410100	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4015	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S4	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307012H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BTD2516	FDA UDI	Class I	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S2HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4510-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S2	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20082-16	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S2HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4016-25	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZCS-R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4511-25	FDA UDI	Class II	Active
Kerator	AS357	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC25065S	FDA UDI	Class II	Active
Kerator	PA353	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4515R	FDA UDI	Class II	Active

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