A-dec

FDA UDI

Class I (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name: A-dec FDA UDI
Generic Name: Dental delivery system irrigation handpiece FDA UDI
Device Name: Syringe Head,Mini,Pencil FDA UDI
Model / Reference: 23.1249.00 FDA UDI
Description: Syringe Head,Mini,Pencil FDA UDI

Identifiers

Catalog Number: 23.1249.00 FDA UDI
Primary DI / UDI-DI: 10194665002091 FDA UDI
510(k) Number: K931137 FDA UDI
FDA Product Code: ECB FDA UDI
GMDN Term: Dental delivery system irrigation handpiece FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental delivery system irrigation handpiece

A-dec by A-Dec, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K931137 also covers:

A-dec — A-Dec, Inc.
A-dec — A-Dec, Inc.

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: A-Dec, Inc.

Sources (1)

FDA UDI 5ef1154c-1839-4d14-9b2b-b356cd97fc7f 35 fields · synced May 31, 2026