Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009537528

FEI Number

3009537528

Entity Name

POLYMER ENGINEERING LABORATORIES LTD.

City/State/Country

Iwamizawa Hokkaido, JP

Establishment Address

129-18 Okayama-cho, Iwamizawa Hokkaido 079-0181, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Polymer Engineering Laboratories Ltd. (Owner Number: 10039731)

Owner / Operator Contact Address

129-18 Okayama-cho, Iwamizawa, JP-01 079-0181, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2012-02-06

Official Correspondent

Makoto Mura

US Agent Details

Brandon Bernacchi Business: Tangent Orthodontics Email: brandon@tangentortho.com Phone: (317) 2250650

Related Public Records

Same Entity

Polymer Engineering Laboratories Ltd.

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

View Entity Profile →

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
3008005217	US ORTHODONTIC PRODUCTS	Norwalk, CA, US
3009491780	Phoenix Orthodontics Inc	Marietta, GA, US
1833132	G & H Wire Company	Franklin, IN, US
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009537528. Last updated year: 2026. Please use registration number 3009537528 when referencing this establishment in official correspondence.