Manufacturer registered with FDA
Peter Brasseler Holdings, LLC
Savannah, GA, United States. Lists 65 dental device types with FDA across 1 registered establishment.
- Device types listed
- 65
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 424 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Peter Brasseler Holdings, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Peter Brasseler Holdings, LLC | 65 device types | — | Below |
| Colombia | INVIMA | Manufacturer | BRASSELER USA DENTAL LLC | 14 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Brasseler U.S.A. Dental, LLC | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Brasseler U.S.A. Dental, L.L.C. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Peter Brasseler Holdings, LLC currently lists, by FDA device type, with the brand and model names on the listing.
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
Peter Brasseler Holdings, LLC 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: Nakanishi, Inc. (8), Nsk Nakanishi, Inc. (5), Ttbio Corp. (2), J. Morita USA, Inc. (2), Realcloud Imaging Inc. Dba Realcloud Imaging (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1), W&H Dentalwerk Buermoos GmbH (1), Angelus Industria DE Produtos Odontologicos S/A (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Aug 2022 | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | MUH Digital Extraoral Source X-Ray System |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 24 Feb 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | EKX Ac-Powered Direct Drive Handpiece |
| 27 Oct 2020 | K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 12 Dec 2019 | K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | KIF Root Canal Filling Resin |
| 11 Dec 2019 | K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | EFB Dental Air-Powered Handpiece |
| 16 Apr 2019 | K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 11 Oct 2018 | K173920 | LS OIL | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 31 Aug 2017 | K163402 | NLZ Motor System | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 24 Aug 2015 | K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 27 Feb 2015 | K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | Ttbio Corp. | EFB Dental Air-Powered Handpiece |
| 5 Mar 2013 | K113717 | ULTRASONIC SCALER | Nakanishi, Inc. | ELC Ultrasonic Scaler |
| 28 Feb 2013 | K121901 | TI-MAX Z45 | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 20 Jun 2012 | K112024 | TI-MAX X450 | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 4 May 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 17 Apr 2012 | K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | Thunder Tiger Corp. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 5 Apr 2012 | K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT | Handpiece Headquarters, Inc. - Hpr, Inc. | EFB Dental Air-Powered Handpiece |
| 5 Mar 2012 | K113655 | TI-MAX X TURBINE | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 6 Jan 2009 | K082943 | IROOT BP, MODEL IRBP 4609 | Innovative Bioceramix, Inc. | KIF Root Canal Filling Resin |
| 15 Nov 2005 | K053014 | POLY SILOXANE IMPRESSION MATERIAL | Clinician'S Choice Dental Products, Inc. | ELW Impression Material |
| 22 Nov 2004 | K042614 | S&C-SELF ETCH PR-BOND | S & C Polymer GmbH | KLE Resin Tooth Bonding Agent |
| 11 Sep 2001 | K011926 | ELEC-MATE E | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 13 Nov 2000 | K002521 | SPARTAN MTS | Spartan Marketing Group | ELC Ultrasonic Scaler |
| 24 Mar 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 8 Oct 1997 | K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 11 Sep 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BRASSELER U.S.A. DENTAL, LLCFDA reg. 1032227 | SAVANNAH, GA, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Other names on FDA records
Brasseler U.S.A. Dental, L.L.C.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1032227). 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.