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
J2A Dental Implant System	OTF6015R	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR3405A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIASL4502	FDA UDI	Class II	Active
J2C Dental Implant System	MTF3710M	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4510	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S0HB	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5008-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S4HA	FDA UDI	Class II	Active
Kerator	AS356	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD37560S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25406S4	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20506S4HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA203513P	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S3HA	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA505550R	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR3511-25	FDA UDI	Class II	Active
J2R Implant System	JRF5010	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4013-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S2	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4585RP	FDA UDI	Class II	Active
KJ Mini Implant System	OBM3510	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR5008A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2510-18	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD24080S	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA705520R	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	IS500130	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF6013RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS5002	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR3405A20	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20103-16	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4515	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR4012-25D	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S1	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA306014H	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF375080	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4516D	FDA UDI	Class II	Active
J2E Implant System	CR501070H	FDA UDI	Class II	Active
J2E Implant System	JEF5010S	FDA UDI	Class II	Active
J2C Dental Implant System	MTF4085R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4008-25D	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA455540R	FDA UDI	Class II	Active
J2E Implant System	CW604055NH	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5013RP	FDA UDI	Class II	Active
Kerator Metal Cap	CW	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2014-18	FDA UDI	Class II	Active
J2E Implant System	CR602040NH	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF410080	FDA UDI	Class II	Active
Kerator	BC303	FDA UDI	Class II	Active
KJ Mini Implant System	MIA45010A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S3HA	FDA UDI	Class II	Active

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