FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919659501
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5021262U0
Device description
NL9000S HIGHSPEED 1P
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EFBHandpiece, air-powered, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919659501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919659501008879196595018879196595010887919659501

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, pneumaticA pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08404535019247Brasseler USA5031780U05031780U02026-03-24
08404535024906Brasseler USA5032029U05032029U02026-03-23
08404535024937Brasseler USA5032030U05032030U02026-03-23
08404535024968Brasseler USA5032031U05032031U02026-03-23
08404535025156LARGE BONE BLADESBR1-12100-50BR1-12100-502026-03-23
08404535024579Brasseler USAFL17CHP5032016U02026-03-17
08404535024609Brasseler USAFL17MHP5032017U02026-03-17
08404535024630Brasseler USAFL17FHP5032018U02026-03-17
08404535024661Brasseler USAFL17UF5032019U02026-03-17
08404535021769BrioPrep Sterile Diamonds5031856U05031856U02025-11-21
08404535021790BrioPrep Sterile Diamonds5031857U05031857U02025-11-21
08404535021820BrioPrep Sterile Diamonds5031858U05031858U02025-11-21
08404535021851BrioPrep Sterile Diamonds5031859U05031859U02025-11-21
08404535021882BrioPrep Sterile Diamonds5031860U05031860U02025-11-21
08404535021912BrioPrep Sterile Diamonds5031861U05031861U02025-11-21
08404535021943BrioPrep Sterile Diamonds5031862U05031862U02025-11-21
08404535021974BrioPrep Sterile Diamonds5031863U05031863U02025-11-21
08404535022001BrioPrep Sterile Diamonds5031864U05031864U02025-11-21
08404535022124BrioPrep Sterile Diamonds5031880U05031880U02025-11-21
08404535022155BrioPrep Sterile Diamonds5031881U05031881U02025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J00716009110011CA 8:1BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-05-22
J00716014150011smartIPRBien-Air Dental SAEFB2026-03-20
008171690239203D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
008171690239373D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
00817169028017Hydrolux by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
J00716014030011PM OSCILLATING IPRBien-Air Dental SAEFB2026-01-23
03609820101286BUSE PERIO MAINT AIR N GO EASYSATELECEFB2025-12-10
J0071600386001USA1CA 1:5 LBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-12-05
J021020835000MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021063951001MCA-QC-RMW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021064226001MCA-QC-ISOW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600677001USA1MOT MX2BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
J0071600755001USA1MOT MX-i LEDBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
04589551393367PANA SPRAY PlusNAKANISHI INC.EFB2025-09-24
D178F160Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC164K1Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC165K1Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC170Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
J00716014110011CA Midwest® lmplant 20:1 LBien-Air Dental SAEFB2025-08-14
00810021437835DCI EdgeDCI International, LLCEFB2025-08-11
06971119540036Dental Low-Speed Turbine HandpieceGuangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540135Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540142Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540159Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540166Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540173Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540180Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540197Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540203Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15
06971119540227Dental High-Speed Turbine Handpiece Guangdong JINME Medical Technology Co., Ltd.EFB2025-07-15