FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919759799
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5025454U0
Device description
PPR3 PRICHARD RASPATORY 1P
Published
2022-12-08
Public version status
Update
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
EMRFILE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919759799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919759799008879197597998879197597990887919759799

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. 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
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840018665767Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00840018665774Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00841336110854Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2024-12-11
00813677024756PDT, Inc.PDT, INC.EMR2024-05-22
00842517113688Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517118973Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119048Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119055Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517106093Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106130Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00841336101203Salvin Freer Periosteal ElevatorsSalvin Dental Specialties, Inc.EMR2023-08-10
00841336101227Salvin Hirschfeld #20 Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102286Salvin Goldman-Fox Periosteal Elevator - 17cmSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102385Salvin Molt 9Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102460Salvin West Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102859Salvin Woodson Elevator - 7" (18cm)Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102866Salvin Bone File #12Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102873Salvin Bone File #10Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102880Salvin Bone File # 12CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102897Salvin Bone File # 10CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104150Salvin Molt #2 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104167Salvin Molt 4 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104181Salvin Periosteal-Tome™ Combination Periosteal Elevator & PeriotomeSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104280Salvin Prichard ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104327PCHARLES Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105423Papilla Elevator BlackSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105447Prichard BlackSalvin Dental Specialties, Inc.EMR2023-08-10
10889950012304Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMR2023-06-27