4.0 x 10mm Simpler Push in HA Implant

FDA UDI

Class II (US FDA UDI)

by Simpler Implant Solutions Inc

Identity

Trade Name: 4.0 x 10mm Simpler Push in HA Implant FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Simpler 4.0 x 10mm Push in Hydroxylapatite coated dental implant. FDA UDI
Model / Reference: S 5006 FDA UDI
Description: Simpler 4.0 x 10mm Push in Hydroxylapatite coated dental implant. FDA UDI

Identifiers

Catalog Number: S 5006 FDA UDI
Primary DI / UDI-DI: D780S50060 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: 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, two-piece

4.0 x 10mm Simpler Push in HA Implant by Simpler Implant Solutions Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Simpler Implant Solutions Inc

Sources (1)

FDA UDI f5846664-0ad6-43d2-8db6-72b1004290a8 35 fields · synced May 30, 2026