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	OBM2510	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254012H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5012-25	FDA UDI	Class II	Active
Kerator	B503	FDA UDI	Class II	Active
Kerator	PA455	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30406S4HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S4HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20406S3HA	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDD35065S	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF450150	FDA UDI	Class II	Active
KJ Submerged System	ITX-4009	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30408S2	FDA UDI	Class II	Active
Kerator	B404	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S3	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454030M	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - SH Abutment	PTAB36056S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BHPRH	FDA UDI	Class I	Active
J2I Implant System	JIF41130	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF600100	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4507RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2515-18	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455520R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA306511S2HB	FDA UDI	Class II	Active
KJ Submerged System	ITX-6012H	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4512	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR2011-18	FDA UDI	Class II	Active
Kerator	PA355	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2014-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S3HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4015-25D	FDA UDI	Class II	Active
Kerator	B501	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA705530R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S1HA	FDA UDI	Class II	Active
J2E Implant System	CW602040H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25509S0HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S3	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5012-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3010-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25408S1	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDC25080S	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4512	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20408S4HA	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5016-25	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1410	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA36580S	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3512-18	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BTD7016	FDA UDI	Class I	Active
KJ Mini Implant System	MIASS3404	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3016-18	FDA UDI	Class II	Active
KJ Mini Implant System	OBM5012	FDA UDI	Class II	Active

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