FDA.reportPublic FDA data

26/27S Ball Burnisher

Primary DI
00810060722046
Brand
26/27S Ball Burnisher
Company
Berman Instruments LLC
Model
BB267
Published
2022-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060722046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060722046008100607220468100607220460810060722046

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, resinA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118744340
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060722015Adson Tissue ForcepsAF0012022-09-22
00810060722039Aspirating Syringe 1.8 mlAS0182022-09-22
00810060722077Lucas Curette #85BC085 2022-09-22
00810060722084Lucas Curette #87BC0872022-09-22
00810060722091Lucas Curette #88BC0882022-09-22
008100607221072R/2L Columbia Curette CC022 2022-09-22
008100607221144R/4L Columbia Curette CC044 2022-09-22
0081006072212113/14 Columbia CuretteCC1342022-09-22
008100607221381/2 Gracey CG012 2022-09-22
0081006072214511/12 Gracey CG112 2022-09-22
0081006072215213/14 Gracey CG134 2022-09-22
0081006072220613K/TG Kirkland Periodontal ChiselCKP13 2022-09-22
008100607222204 Ochsenbein Surgical Chisel, 3.4 mmCOS04 2022-09-22
00810060722237College Pliers, Serrated Tips CP001 2022-09-22
00810060722244113 Non-serrated Cord Packer CP113 2022-09-22
00810060722251College Pliers, Self-locking, Serrated Tips CPL02 2022-09-22
00810060722558Rubber dam punch DF002 2022-09-22
00810060722657Molt #2 Surgical CuretteEP002 2022-09-22
00810060722930Molt Mouth Prop - Adult MA002 2022-09-22
00810060722947Metal Bowl - Prep CupMBPC352 2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD28020Surgical DirectSurgical Direct, Inc.EKJ2026-07-31
00850083275655Intrace USAPILOTIS TECH LLCEKJ2026-07-03
00348783009378Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009385Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
07898506843459QuinelatoSchobell Industrial LtdaEKJ2022-12-08
00841013101892American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013102059American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013109607American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013101878American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101908American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101915American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101922American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101939American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101946American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101953American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013102004American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23