Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024787345

FEI Number

3024787345

Entity Name

BATTECH

City/State/Country

Irvine, CA, US

Establishment Address

5 Taylor, Irvine, CA 92620, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

battech (Owner Number: 10086358)

Owner / Operator Contact Address

5 Taylor, Irvine, CA 92620, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pre Bent Needle Tips, Mixing Tips, irrigation syringe, dental needle dental mixing tips Wrap, sterilization, Indicator, physical/chemical sterilization process dental paper tray cover Drape, surgical, exempt dental micro applicator Denture Box dental plastic chair cover Suction connection tube, Aspiration Tube orthodontics elastic band Aligner chewies dental blade dental barrier film Handheld Light Protection Shield Dental Plastic File Holder with Measuring Dental Safety Goggles dental plastic/wooden wedge dental cheek retractor Dappen dish Tray;lmpression Tray; Impression Tray Base; Tray Base;Teeth-whiten tray dental plastic file holder dental stainless steel tongue scraper safety glasses/ safety goggles Spatula Aligner removal tool/ Aligner removal tool/Aligner removal tool/ Aligner removal tool Bandage, Elastic Mouth Props.ENDO MEASURE BLOCK.ENDO CLEAN BLOCK;ENDO Ring and Chshions; Poly Wedge;wooden wedge; Silicone Rubber Mixing dental prebent tips Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip.Curved Utility Syringes, HP Mixing Tip dental shaped hand mirror Gauze/sponge, internal, x-ray detectable dental divided tray dental flat tray dental arch wire, Stainless Steel Kobyashi Wire, Braces Wire, Orthodontic Dental Ligature Wire non-woven shoes cover Bib Clip; Cotton Roll Clips dental brackets dental disposable chair cover dental cotton sponge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2024-03-06
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2024-03-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2026-05-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2026-05-06
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2024-03-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-05-06
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-03-06
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-03-06
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2024-03-06
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2025-12-21
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2025-12-18
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2023-08-09
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2024-03-06
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-03-06
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2023-08-09
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2024-03-06
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-08-09
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2024-03-06
QIA	Powered Tongue Scraper	Dental	Class 1	872.6865	2024-03-06
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2024-03-06
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-03-06
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2024-03-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-05-06
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-03-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2023-08-09
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2023-08-09
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-03-06
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2026-05-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-03-06
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-03-06
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2024-03-06
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2024-03-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-03-06
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-03-06
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-03-06

Official Correspondent

Alice Liu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

battech

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
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.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024787345. Last updated year: 2026. Please use registration number 3024787345 when referencing this establishment in official correspondence.