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	MIAS5015	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3514-25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS4008-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBL4013D	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR4508A15	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS4005	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS2012-18	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA203512H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS3508-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BFD30H	FDA UDI	Class I	Active
LOTA HA Dental Implant System	LOTA204009H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25508S1HB	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S1HA	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MS-1610	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA305508H	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4514	FDA UDI	Class II	Active
J2I Implant System	JIF41100	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454050R	FDA UDI	Class II	Active
J2E Implant System	CR603070H	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR30508S2	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS4015	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25659S0	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25409S4	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR3512-25	FDA UDI	Class II	Active
J2E Implant System	JEF6008S	FDA UDI	Class II	Active
KJ Mini Implant System	MIAA25	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA254514H	FDA UDI	Class II	Active
KJ Mini Implant System	MIAR6005A15	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA307013H	FDA UDI	Class II	Active
Kerator	AOF4010	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BID2016	FDA UDI	Class I	Active
LOTA SLA Dental Implant System	LOTA204010P	FDA UDI	Class II	Active
J2R Implant System	EZA6T2	FDA UDI	Class II	Active
J2E Implant System	CW704055NH	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA507010R	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	BLMD16	FDA UDI	Class I	Active
Hero 2 & IS Dental Implant System	IS400100	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDA35012S	FDA UDI	Class II	Active
KJ Mini Implant System	MIA4008A25	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4511-25D	FDA UDI	Class II	Active
Kerator	B504	FDA UDI	Class II	Active
KJ Submerged System	ITX-4510	FDA UDI	Class II	Active
Anchor Plus/Neo Anchor Plus	MSS-1608	FDA UDI	Class II	Active
KJ Submerged System	ITX-4512H	FDA UDI	Class II	Active
KJ Mini Implant System	MIASS4003	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25659S2	FDA UDI	Class II	Active
J2E Implant System	CR501040H	FDA UDI	Class II	Active
KJ Mini Implant System	MIAS4505	FDA UDI	Class II	Active
KJ Mini Implant System	MIA3405A20	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S3	FDA UDI	Class II	Active

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