Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1032227

FEI Number

1032227

Entity Name

BRASSELER U.S.A. DENTAL, LLC

City/State/Country

SAVANNAH, GA, US

Establishment Address

1 Brasseler Blvd, SAVANNAH, GA 31419, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PETER BRASSELER HOLDINGS, L.L.C. (Owner Number: 1032227)

Owner / Operator Contact Address

1 BRASSELER BLVD., Savannah, GA 31419, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011926

PMA Number

N/A

All Registered Proprietary Names

EdgePro Core Build Up Brasseler USA Bur Block VersaFlex Disc Forza + Forza + Brasseler Irrigation solutions Dental KIts Brasseler Electric Motor Brasseler Forza Attachments Brasseler Electric Motor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2007-12-03
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2007-12-03
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-07
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2006-09-20
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-12-03
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-03-31
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2026-03-31
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2012-09-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-04-11
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2016-11-21
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2006-09-20
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2016-06-07
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	1996-07-18
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-12-27
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-12-04
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-07-25
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1996-07-18
EKE	Curette, Operative	Dental	Class 1	872.4565	2012-10-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2026-03-02
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2023-07-24
EMR	File, Periodontic	Dental	Class 1	872.4565	2012-10-17
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2007-08-02
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2013-01-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-07-25
EIS	Remover, Crown	Dental	Class 1	872.4565	2007-12-03
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-07-25
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-07
EKM	Gutta-Percha	Dental	Class 1	872.3850	2004-06-14
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-08-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2006-09-20
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2025-03-10
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	1996-07-18
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2026-01-06
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2007-12-03
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2026-01-06
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2007-12-03
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
EKB	Explorer, Operative	Dental	Class 1	872.4565	2007-12-03
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2016-06-07
HWK	Trephine	Orthopedic	Class 1	888.4540	2012-10-18
EHL	Point, Abrasive	Dental	Class 1	872.6010	2012-09-27
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2012-10-17
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
ELW	Material, Impression	Dental	Class 2	872.3660	2024-06-28
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-06-28
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2007-12-03
EJL	Bur, Dental	Dental	Class 1	872.3240	1983-11-09
ELR	Post, Root Canal	Dental	Class 1	872.3810	2004-06-14
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2004-06-14
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2023-07-24
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2007-12-03
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-11-15
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2016-03-30
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2007-12-03
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2023-07-26
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-07-26
DZM	Needle, Dental	Dental	Class 1	872.4730	2016-06-07
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-07-25
LQY	Locator, Root Apex	Unknown	Class U	N/A	2023-07-25
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-04-29
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2013-01-28
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-07-25
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2024-04-30
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-07-25
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2007-12-03
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2024-08-28
EIG	Retractor, All Types	Dental	Class 1	872.4565	2013-01-25
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2004-06-14
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-07-25
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2007-12-03
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2007-12-03
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	1996-07-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-07-31
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2007-12-03
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2023-07-25

Official Correspondent

Carl Mazzolini

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PETER BRASSELER HOLDINGS, L.L.C.

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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700

Similar Registrations

Registration Number	Establishment Name	Location
3015398570	MEISTER SURGICAL INSTRUMENTS	Sialkot Punjab, PK
3007773213	SITEC (PVT.) LTD.	SIALKOT Punjab, PK
3008808049	SURGICRAFTS	Sialkot Punjab, PK
9613083	TOWNE BROTHERS (PVT.), LTD.	SIALKOT Punjab, PK
3036756245	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Perai Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1032227. Last updated year: 2026. Please use registration number 1032227 when referencing this establishment in official correspondence.