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4.0mm x 15 mm Simpler One Threaded HA Dental Implants

FDA UDI

Class II (US FDA UDI)

by Simpler Implant Solutions Inc

Identity

Trade Name
4.0mm x 15 mm Simpler One Threaded HA Dental Implants FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
4.0 mm diameter x 15 mm length Simpler One surgery Threaded hydroxylapatite (HA) coated dental implant FDA UDI
Model / Reference
S1T 5008 FDA UDI
Description
4.0 mm diameter x 15 mm length Simpler One surgery Threaded hydroxylapatite (HA) coated dental implant FDA UDI

Identifiers

Catalog Number
S1T 5008 FDA UDI
Primary DI / UDI-DI
D780S1T50080 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

4.0mm x 15 mm Simpler One Threaded HA Dental Implants by Simpler Implant Solutions Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Simpler Implant Solutions Inc

Sources (1)

  • FDA UDI f44e80db-1304-4b54-b695-9d92f1c3cea4 36 fields · synced May 30, 2026