3.0 mm x 15mm Simpli Maximini HA O Ring Implants

FDA UDI

Class II (US FDA UDI)

by Simpler Implant Solutions Inc

Identity

Trade Name: 3.0 mm x 15mm Simpli Maximini HA O Ring Implants FDA UDI
Generic Name: Screw endosteal dental implant, one-piece FDA UDI
Device Name: Simpli Simpler O Ring hydroxylapatite (HA) coating One Piece dental implants FDA UDI
Model / Reference: SOS 5315 FDA UDI
Description: Simpli Simpler O Ring hydroxylapatite (HA) coating One Piece dental implants FDA UDI

Identifiers

Catalog Number: SOS 5315 FDA UDI
Primary DI / UDI-DI: D780SOS53150 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Screw endosteal dental implant, one-piece

3.0 mm x 15mm Simpli Maximini HA O Ring Implants by Simpler Implant Solutions Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, one-piece.

Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
KJ Mini Implant System — Kj Meditech · Class II
VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
Zirlux — HENRY SCHEIN, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
KJ Mini Implant System — Kj Meditech · Class II
Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Simpler Implant Solutions Inc

Sources (1)

FDA UDI 9157a740-f555-478c-9398-81e24f7a47b7 35 fields · synced Jun 8, 2026