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	MIPS4013-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4008-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S4HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIA34010A15	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307014H	FDA UDI	Class II	Active
Kerator	B402	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA705550R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA256511S3HA	FDA UDI	Class II	Active
KJ Submerged System	ITX-5011H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S4	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2516-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	ZBTD40	FDA UDI	Class I	Active
KJ Mini Implant System	MIBR3512-25	FDA UDI	Class II	Active
J2R Implant System	JRANALN	FDA UDI	Class I	Active
Two-Piece Type Abutments	TWA505520R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4516-25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA304509H	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4313RP	FDA UDI	Class II	Active
J2E Implant System	CR603070NH	FDA UDI	Class II	Active
KJ Submerged System	ITX-6011	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS5013-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBL5013D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR5016-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30508S2	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S3	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4508	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA604030R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD36580S	FDA UDI	Class II	Active
J2R Implant System	JRHAR605	FDA UDI	Class II	Active
J2E Implant System	CR502040H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30659S4	FDA UDI	Class II	Active
KJ Mini Implant System	OBL3513	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5007RP	FDA UDI	Class II	Active
J2E Implant System	CM404070H	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4315RP	FDA UDI	Class II	Active
J2R Implant System	JRF5011	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4010-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA306012P	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3508-18	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA204010H	FDA UDI	Class II	Active
J2E Implant System	CW603040NH	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS400073	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1607	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD24065S	FDA UDI	Class II	Active
J2E Implant System	JEF4514S	FDA UDI	Class II	Active
J2E Implant System	CR603055NH	FDA UDI	Class II	Active
Kerator	PA354	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4014	FDA UDI	Class II	Active
KJ Mini Implant System	OBL3511	FDA UDI	Class II	Active

Kj Meditech

What Kj Meditech makes

Frequently asked questions

Information

Catalogue (2116)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)