Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004158247

FEI Number

3004158247

Entity Name

SPECIALTY APPLIANCES, LLC

City/State/Country

CUMMING, GA, US

Establishment Address

4905 HAMMOND INDUSTRIAL DRIVE, CUMMING, GA 30041, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SPECIALTY APPLIANCES, LLC (Owner Number: 9058539)

Owner / Operator Contact Address

4905 HAMMOND INDUSTRIAL DRIVE, Cumming, GA 30041, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Relief Wax Orthodontic Bands Clear Image Aligners Traditional Crimpable Shims M4 Mechanism Specialty 4 Part MiniScope Mechanism Traditional Herbst Mechanism Traditional Round Shims Herbst Component Parts Specialty MiniScope Mechanism Herbst AppleCore Screws Traditional Herbst Round Pivots Traditional Herbst Hex Screw Telescoping Crimpable Shims OSD-1434-04C Chewies

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2003-09-12
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2003-09-12
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2022-11-16
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-02-28
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-26
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-07-10
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2024-06-21
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2012-02-23
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2019-08-06
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2012-02-23
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2024-06-21
EJL	Bur, Dental	Dental	Class 1	872.3240	2024-11-14
ELW	Material, Impression	Dental	Class 2	872.3660	2024-02-19
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2024-04-05

Official Correspondent

James Kirk

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPECIALTY APPLIANCES, LLC

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
K161684	Reliance Orthodontic Products, Inc.	Quantum LB	2016-10-06
K810210	Sci-Pharm, Inc.	MAGIC-TOUCH	1981-02-10
K875144	Reliance Orthodontic Products, Inc.	EXCEL FAST SET	1988-02-26
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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
3025769679	RB DENTAL	Seoul, KR
3006007013	PARK-ISTRE, LLC.	DALLAS, TX, US
3016564992	DENTAC LLC	North Miami, FL, US
3042903603	CERLUCENT, LLC	Norwalk, CA, US
3027989276	NORTHWEST DENTAL	Hartland, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004158247. Last updated year: 2026. Please use registration number 3004158247 when referencing this establishment in official correspondence.