5x8 Simpli Simpler One Piece GBAE Dental Implants

FDA UDI

Class II (US FDA UDI)

by Simpler Implant Solutions Inc

Identity

Trade Name: 5x8 Simpli Simpler One Piece GBAE Dental Implants FDA UDI
Generic Name: Screw endosteal dental implant, one-piece FDA UDI
Device Name: 5 x 8mm Simpli Simpler One Piece Grit Blasted Acid Etched Dental Implant for Crown and Bridge FDA UDI
Model / Reference: S1S 3508 FDA UDI
Description: 5 x 8mm Simpli Simpler One Piece Grit Blasted Acid Etched Dental Implant for Crown and Bridge FDA UDI

Identifiers

Catalog Number: S1S 3508 FDA UDI
Primary DI / UDI-DI: D780S1S35080 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

5x8 Simpli Simpler One Piece GBAE Dental Implants 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 a271a3fb-61bc-48ed-8016-aad418d7d127 35 fields · synced May 30, 2026