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 ZIRCONIA Implant System	ZROBS4510	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA404020R	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5010R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SD34065S	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA605510R	FDA UDI	Class II	Active
Hero 1 Dental Implant System	MZF600115	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4511	FDA UDI	Class II	Active
KJ Mini Implant System	MIPSW20153-16	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20509S2HA	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF4307RP	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB26050S	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA30509S1	FDA UDI	Class II	Active
Kerator	SRS504	FDA UDI	Class II	Active
J2A Dental Implant System	OTF4085R	FDA UDI	Class II	Active
J2R Implant System	JRTAN-E	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR2013-18	FDA UDI	Class II	Active
J2R Implant System	JRHAR453	FDA UDI	Class II	Active
KJ Mini Implant System	MIBR5016-25D	FDA UDI	Class II	Active
KJ Mini Implant System	MIPR4010-25D	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF5015RP	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4015-25	FDA UDI	Class II	Active
KJ Submerged System	ITX-6011H	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA203511H	FDA UDI	Class II	Active
KJ ZIRCONIA Implant System	ZROBS5013	FDA UDI	Class II	Active
Kerator	B336	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20409S2HA	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA20508S1	FDA UDI	Class II	Active
Hero 2 & IS Dental Implant System	MAF500100	FDA UDI	Class II	Active
J2A SLA Dental Implant System	OTF4385RP	FDA UDI	Class II	Active
KJ Submerged System	ITX-6010H	FDA UDI	Class II	Active
J2A Dental Implant System	OTF6013R	FDA UDI	Class II	Active
KJ SUBMERGED SYSTEM - Solid Abutment	SDB25065S	FDA UDI	Class II	Active
KJ Submerged System	ITX-4508	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSAR25509S2	FDA UDI	Class II	Active
Kerator Cap	CPD2	FDA UDI	Class II	Active
J2C SLA Dental Implant System	MTF5010RP	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA455520M	FDA UDI	Class II	Active
J2C Dental Implant System	MTF5010R	FDA UDI	Class II	Active
J2A Dental Implant System	OTF5085R	FDA UDI	Class II	Active
Kerator	PA351	FDA UDI	Class II	Active
LOTA SLA Dental Implant System	LOTA254513P	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA454030R	FDA UDI	Class II	Active
LOTA HA Dental Implant System	LOTA305509H	FDA UDI	Class II	Active
KJ Mini Implant System	MIBS4513-25	FDA UDI	Class II	Active
LOTA SLA Dental Implant System and LOTA HA Dental Implant System	LTSA25506S1	FDA UDI	Class II	Active
One-Piece Type Abutments	OPA405540R	FDA UDI	Class II	Active
KJ Mini Implant System	MIPS3512-25	FDA UDI	Class II	Active
KJ Mini Implant System	OBM4013	FDA UDI	Class II	Active
Two-Piece Type Abutments	TWA607050R	FDA UDI	Class II	Active
J2E Implant System	CR601040H	FDA UDI	Class II	Active

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