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	LTSA25406S3HA	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5013	FDA UDI	Class II	Active
Kerator	SRS350	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305512P	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307009H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2515-18	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1408	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S1	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	DE	FDA UDI	Class I	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S0HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIA60010A25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305013P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S2HA	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF450130	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4013RP	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S4HB	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5507R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	ZBTD50	FDA UDI	Class I	Active
J2E Implant System	JEF4508S	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS5013-25	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF600100	FDA UDI	Class II	Active
J2I Implant System	ISA4870	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA304514H	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1612	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4505A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR5008A15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254511P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S2HB	FDA UDI	Class II	Active
J2E Implant System	CR501055NH	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3514-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203514P	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3510-25	FDA UDI	Class II	Active
J2I Implant System	ISA4840	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3510-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA305510P	FDA UDI	Class II	Active
J2I Implant System	JIFW48130	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2011-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3013-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA306009P	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA605530R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD36565S	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1607	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S2HA	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBL3513	FDA UDI	Class II	Active
J2E Implant System	JEF3818S	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF6015RP	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA457050M	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2013-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3013	FDA UDI	Class II	Active
J2R Implant System	JRHAR603	FDA UDI	Class II	Active

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