Registered with FDA
ATOMO Dental, Inc.
Pleasanton, CA, United States. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What ATOMO Dental, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Saliva ejector, Evacuator tips | 2014 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | disposable dental Syringe, Air/Water Syringe tips | 2014 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | LED Whitening Light, LED Curing Light | 2015 |
| Roll CottonEFN · Class 1 | — | Lister | Cotton Roll | 2015 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Toothbrush | 2015 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | PROPHY ANGLE | 2022 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups | 2015 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Dental Impression Tray, Bite Registration Tray, Disposable Impression Tray | 2016 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Dynamic HP Mixing Tips; Bent Needle Tips; Curved Utility Syringe; Dispensing Tips; Impression Gun; Intra-Oral Tips | 2016 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | baby tooth box; box; plastic dappen | 2015 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Lister | Disposable traps( filter); Plastic retainer/ denture; cuspidor strainer; amalgam carrier | 2015 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Dental floss | 2015 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Dental bib / apron | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Micro Applicator; Valustick Sticky Applicator; Bendable brush applicator; composite brush and replaceable tip | 2015 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | ATOMO air compressor and vacuum unitBarrier Film; Handpiece Sleeves; Instrument Tray Sleeves; Light/Sensor Sleeves/Pouches; Barrier Sleeves; Syringe SleevesDental Tray Cover, Headrest Cover, Intraoral Camera Sheath | 2014 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | ATOMO dental chair | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
ATOMO Dental, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Premium Plus International Limited (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Dec 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ATOMO DENTAL, INC.FDA reg. 3011279497 | Pleasanton, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047993). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.