Universal Orthodontic Lab, Inc.

FDA Device Registration & Listing · Norwalk, CA, US · Registration 3007010296

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007010296
FEI Number
3007010296
Entity Name
Universal Orthodontic Lab, Inc.
City/State/Country
Norwalk, CA, US
Establishment Address
11917 Front Street, Norwalk, CA 90650, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Universal Orthodontic Lab, Inc. (Owner Number: 10025859)
Owner / Operator Contact Address
11917 Front Street, Norwalk, CA 90650, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pliers Dental Wax Saliva Ejector RETAINER, MOUTHGUARD, BITEGUARD Orthodontic Band Elastic Orthodontic Band

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EEA Plate, Base, Shellac Dental Class 1 872.6200 2020-05-13
JEX Plier, Orthodontic Dental Class 1 872.4565 2013-11-08
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2013-11-11
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2013-11-08
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2008-05-30
DYO Band, Material, Orthodontic Dental Class 1 872.5410 2013-11-08
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2013-11-08
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2020-05-13
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2008-05-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Universal Orthodontic Lab, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007513373 E. TEC SA DE C.V. Tijuana Baja California, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04

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 307850***DISTRIBUTED 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 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 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.
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007010296. Last updated year: 2026. Please use registration number 3007010296 when referencing this establishment in official correspondence.
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