AquaSept

FDA UDI

Class I (US FDA UDI)

by Genesis Dental Technologies, Llc

Identity

Trade Name: AquaSept FDA UDI
Generic Name: Dental delivery system FDA UDI
Device Name: AquaSept Air/Water Syringe System FDA UDI
Model / Reference: 10008 FDA UDI
Description: AquaSept Air/Water Syringe System FDA UDI

Identifiers

Catalog Number: 10008 FDA UDI
Primary DI / UDI-DI: 00736239100081 FDA UDI
510(k) Number: K934436 FDA UDI
FDA Product Code: EIA FDA UDI
GMDN Term: Dental delivery system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental delivery system

AquaSept by Genesis Dental Technologies, Llc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Genesis Dental Technologies, Llc

Sources (1)

FDA UDI c8f61bbb-ab44-4eb0-9c2f-f2353638776d 35 fields · synced Jun 8, 2026