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 SUBMERGED SYSTEM - SH Abutment	PTAB36054S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2513-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4512D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S4HB	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA306013H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S3HB	FDA UDI	Class II	Active
Kerator	KMD619	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB23565S	FDA UDI	Class II	Active
J2R Implant System	JRF3510	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1407	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S4HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR6008A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30406S4	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4510R	FDA UDI	Class II	Active
KJ Submerged System	ITX-6012	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454040R	FDA UDI	Class II	Active
J2E Implant System	JEF3314S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2508-18	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5510RP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405520M	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF375150	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4005A15	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S2HA	FDA UDI	Class II	Active
Kerator Abutment	AT406	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD26050S	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB2362S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S4	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S4HA	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4513R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4515-25	FDA UDI	Class II	Active
Kerator Abutment	AT403	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA204008H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS2511-18	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4508A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2015-18	FDA UDI	Class II	Active
KJ Submerged System	ITX-5012H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S1HA	FDA UDI	Class II	Active
Kerator Cap	CPB2	FDA UDI	Class II	Active
Kerator	SRS353	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30509S2	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1412	FDA UDI	Class II	Active
KJ Mini Implant System	MIA3405A25	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455540M	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5015	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA35050S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S4HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2012-18	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5507R	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR5505A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4016-25D	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)