Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2132509

FEI Number

1000220974

Entity Name

ICP, INC.

City/State/Country

Green Bay, WI, US

Establishment Address

3205 Yeager Dr, Green Bay, WI 54311, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ICP, INC. (Owner Number: 9009593)

Owner / Operator Contact Address

3205 YEAGER DR., --, Green Bay, WI 54311, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Guardian

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2026-05-21
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2026-05-21
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2026-03-23
EJL	Bur, Dental	Dental	Class 1	872.3240	2026-05-21

Official Correspondent

Shari Peggs

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICP, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
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2133714	INTER-MED, INC.	Racine, WI, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US
3016789258	EG-MEDACYS DEVICES(SHENZHEN)CO.,LTD	SHENZHEN Guangdong, CN
3014146451	HUBEI V-MEDICAL PRODUCTS CO., LTD.	Xiantao Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2132509. Last updated year: 2026. Please use registration number 2132509 when referencing this establishment in official correspondence.