Question 1

What types of medical devices does Simpler Implant Solutions Inc manufacture?

Accepted Answer

Simpler Implant Solutions Inc specializes in screw endosteal dental implants, which are surgically placed into the jawbone to support dental prosthetics. Their product line includes both one-piece and two-piece designs, with variations like hydroxyapatite (HA)-coated, threaded, push-in, and mini-implants. These implants are tailored for different dental restoration needs, such as single-tooth replacement or broader prosthetic support.

Question 2

Where is Simpler Implant Solutions Inc based?

Accepted Answer

The company is headquartered in the United States. This location aligns with regulatory frameworks like the FDA, which governs the classification and listing of their devices in the U.S. market.

Question 3

Which regulatory registries or databases list Simpler Implant Solutions Inc’s devices?

Accepted Answer

Simpler Implant Solutions Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental implants classified under FDA guidelines, helping healthcare providers and regulators identify and verify the devices.

Question 4

How are Simpler Implant Solutions Inc’s devices classified under regulatory standards?

Accepted Answer

The company’s screw endosteal dental implants fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as implant stability, biocompatibility, and proper surgical techniques.

Device	Model / Reference	Registries	Class	Status
2.5mm x 15mm Simpler HA Toadstool Mini Implant	SMT 5004	FDA UDI	Class II	Active
4.0mm x 8 mm Simpler Push in HA Dental Implants	S5005	FDA UDI	Class II	Active
3 x 15mm Simpli Simpler One Piece GBAE Dental Implant	S1S 5315	FDA UDI	Class II	Active
3 x 10mm Simpli MaxiMini HA O Ring Implants	SOS 5313	FDA UDI	Class II	Active
6 x 8mm Simpli Simpler One Piece HA Dental Implant	S1S 5608	FDA UDI	Class II	Active
4.0 x 13mm Simpler One Threaded Dental Implant	S1T 3007	FDA UDI	Class II	Active
3.25mm x 13mm Simpler One Push in Implant HA	S1 5007	FDA UDI	Class II	Active
5 x 13mm Simpli MaxiMini HA O Ring Dental Implants	SOS 5513	FDA UDI	Class II	Active
6 x 8mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3608	FDA UDI	Class II	Active
5 x 13mm Simpler Threaded Dental Implant	ST 5013	FDA UDI	Class II	Active
3.25 x 15mm Simpler Threaded Dental Implants	ST3004	FDA UDI	Class II	Active
4.0mm x 13mm Simpler Threaded \|Implants	ST 3007	FDA UDI	Class II	Active
3x13mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3313	FDA UDI	Class II	Active
6x13 mm Simpli MaxiMini HA O Ring Dental Implants	SOS 5613	FDA UDI	Class II	Active
3 x 10mm Simpli Simpler One Piece Dental Implant	S1S 3310	FDA UDI	Class II	Active
2.5mm x 13mm Simpler HA Toadstool Mini Implant	SMT 5003	FDA UDI	Class II	Active
6 x 13mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3613	FDA UDI	Class II	Active
2.5mm x 15 Simpler Mini HA Dental Implants	SM 5004	FDA UDI	Class II	Active
6mm x 10mm Simpler HA Coated Threaded Dental Implants	ST 5022	FDA UDI	Class II	Active
3.25 x 15mm Simpler One Threaded Dental Implant	S1T 5004	FDA UDI	Class II	Active
4 x 10mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3410	FDA UDI	Class II	Active
2.5 x 10 Simpler Mini Implants	SM3002	FDA UDI	Class II	Active
4.0mm x 8mm Simpler Threaded Dental Implant	ST 3005	FDA UDI	Class II	Active
4.0 x 15mm Simpler Threaded GBAE Dental Implant	ST 3008	FDA UDI	Class II	Active
4.0mm x 15 mm Simpler One Threaded HA Dental Implants	S1T 5008	FDA UDI	Class II	Unknown
3 x 13mm Simpli Simpler One Piece GBAE Dental Implant	S1S 5313	FDA UDI	Class II	Active
4 x 13 mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3413	FDA UDI	Class II	Active
5 x 13mm Simpli Simpler One Piece GBAE Dental Implant	S1S 3513	FDA UDI	Class II	Active
5 x 15mm Simpli MaxiMini HA O Ring Dental Implants	SOS 5515	FDA UDI	Class II	Active
4x13mm Simpli MaxiMini HA ORing Implants	SOS 5413	FDA UDI	Class II	Active

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