Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011279497

FEI Number

3011279497

Entity Name

ATOMO DENTAL, INC.

City/State/Country

Pleasanton, CA, US

Establishment Address

1241 Quarry Lane, Suite 125, Pleasanton, CA 94566, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ATOMO Dental, Inc. (Owner Number: 10047993)

Owner / Operator Contact Address

1241 Quarry Lane, Suite 125, Pleasanton, CA 94566, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Toothbrush Dental Impression Tray, Bite Registration Tray, Disposable Impression Tray Isolation Gown, Isolation Jacket, Isolation Lab Coat Dental bib / apron Face mask Powder Free Nitrile Examination Gloves LED Whitening Light, LED Curing Light Micro Applicator; Valustick Sticky Applicator; Bendable brush applicator; composite brush and replaceable tip Bouffant Cap Dynamic HP Mixing Tips; Bent Needle Tips; Curved Utility Syringe; Dispensing Tips; Impression Gun; Intra-Oral Tips Intraoral Camera Dental Loupes ATOMO dental chair Hand Sanitizer gel, Alcohol Wipes Powder Free Nitrile Examination Gloves PROPHY ANGLE baby tooth box; box; plastic dappen Coverall Surgical Suit Sterilization Pouch Disposable traps( filter); Plastic retainer/ denture; cuspidor strainer; amalgam carrier Cotton Roll Medical Goggles, model:MG-1 ATOMO air compressor and vacuum unit Dental Tray Cover, Headrest Cover, Intraoral Camera Sheath Barrier Film; Handpiece Sleeves; Instrument Tray Sleeves; Light/Sensor Sleeves/Pouches; Barrier Sleeves; Syringe Sleeves Ultrasonic Cleaner Polycoated Paper Cups; Plastic Cups Disposable Face Masks; KN95 Mask Non-woven Swab (Sponge); all-gauze sponges; Cotton Filled Exodontia Sponges

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2015-04-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2016-07-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2016-07-07
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2015-02-27
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2015-02-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-04-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2015-02-26
KXR	Applicator, Resin	Dental	Class 1	872.3140	2015-02-26
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-02-27
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2016-07-07
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2015-02-26
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-12
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2014-11-22
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-05-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-05-22
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2022-09-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2015-02-27
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-05-23
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2015-02-27
EFN	Cotton, Roll	Dental	Class 1	872.6050	2015-02-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-05-03
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2014-11-22
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2015-04-12
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2015-04-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-02-27

Official Correspondent

Tom Xu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATOMO Dental, 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011279497. Last updated year: 2026. Please use registration number 3011279497 when referencing this establishment in official correspondence.