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	AT303	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BIR30	FDA UDI	Class I	Active
KJ Mini Implant System	MIAR5505A20	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL4008	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3514	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3508-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3516-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4515D	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR55010A25	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457010M	FDA UDI	Class II	Active
Kerator	B505	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD23565S	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA604010R	FDA UDI	Class II	Active
Kerator	SRS452	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4515RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2008-18	FDA UDI	Class II	Active
J2E Implant System	CR601070H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5016-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIA5005A25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S3	FDA UDI	Class II	Active
J2R Implant System	JRICWT1-OT	FDA UDI	Class I	Active
LOTA SLA Dental Implant System	LOTA254509P	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5511R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD24010S	FDA UDI	Class II	Active
J2E Implant System	JEF5018S	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4085RP	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1406	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S3HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR256511S3	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455530R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S0	FDA UDI	Class II	Active
Kerator	SRS450	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BPPA2025	FDA UDI	Class I	Active
J2I Implant System	ISA6570	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS3403	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25506S4	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA307009P	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3515-25	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA507030R	FDA UDI	Class II	Active
KJ Mini Implant System	MIA3408A20	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAMA-N	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4510-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS5003	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S1HB	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS500085	FDA UDI	Class II	Active
Kerator Abutment	AO406	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4005A15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S3HB	FDA UDI	Class II	Active
Kerator	SRS352	FDA UDI	Class II	Active

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