Steri-Sol® System

FDA UDI

Class I (US FDA UDI)

by Anodia Systems

Identity

Trade Name: STERI-SOL® SYSTEM FDA UDI
Generic Name: Dental delivery system FDA UDI
Device Name: Cutting/Cooling Fluid Delivery System for Dental High-Speed Handpiece Drills that Dispenses a cooling/cutting fluid, Steri-Sol® Solution during Dental Operative Procedures. FDA UDI
Model / Reference: (01)00854542008044(21)101920213030 FDA UDI
Description: Cutting/Cooling Fluid Delivery System for Dental High-Speed Handpiece Drills that Dispenses a cooling/cutting fluid, Steri-Sol® Solution during Dental Operative Procedures. FDA UDI

Identifiers

Catalog Number: ITEM #: MAK-STERI FDA UDI
Primary DI / UDI-DI: 00854542008044 FDA UDI
510(k) Number: K882491 FDA UDI
FDA Product Code: EFB FDA UDI
GMDN Term: Dental delivery system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4200 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental delivery system

Steri-Sol® System by Anodia Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental delivery system.

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Forest — Ls Enterprises, Inc. · Class I
Forest — Ls Enterprises, Inc. · Class I
TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
Forest — Ls Enterprises, Inc. · Class I
A5 SINGLE CART — CEFLA s.c. · Class IIa
Forest — Ls Enterprises, Inc. · Class I

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: Anodia Systems

Sources (1)

FDA UDI 855b31b5-86b2-44d0-8c25-0e04e5be5dbf 36 fields · synced May 30, 2026