FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955BC169521
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
BC1695-2
Device description
BANDITT BONE CONDENSER, LARGE
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D955BC169521PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
10860011605703Surgi-StopSDWD-01 2024-01-29
D9553300KEY1Paul Banditt3300-KEY 2023-12-11
D95543411Paul Banditt434-1 2023-12-11
D955BC169511Paul BandittBC1695-12023-12-11
D955BCU0R0L1Paul BandittBCU0R0L 2023-12-11
D955BCU1R1L1Paul BandittBCU1R1L 2023-12-11
D955BCU2R2L1Paul BandittBCU2R2L 2023-12-11
D955BCU71001Paul BandittBCU7100 2023-12-11
D955BCU71101Paul BandittBCU7110 2023-12-11
D955BCU71201Paul BandittBCU7120 2023-12-11
D955BCU72521Paul BandittBCU7252 2023-12-11
D955BCU72541Paul BandittBCU7254 2023-12-11
D955BCU9361Paul BandittBCU936 2023-12-11
D955BCUM11Paul BandittBCUM1 2023-12-11
D955BCUM21Paul BandittBCUM2 2023-12-11
D955BCUM241Paul BandittBCUM24 2023-12-11
D955BCUM31Paul BandittBCUM3 2023-12-11
D955BCUM41Paul BandittBCUM4 2023-12-11
D955BCUM7L1Paul BandittBCUM7L 2023-12-11
D955BCUM7R1Paul BandittBCUM7R 2023-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535019247Brasseler USAPeter Brasseler Holdings, LLCEKR2026-03-24
00348783008968Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009040Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009064Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009071Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00840018667525Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKR2026-02-10
06941877827816ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
06941877827823ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
E896169520SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-05-19
E896169710007E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
E89616971TI06E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
08806383586313DUO-GUNDiaDent Group InternationalEKR2025-03-12
08806383586320DUO-PENDiaDent Group InternationalEKR2025-03-12
06944843619071EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06944843619088EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06970873260389Integrated Endo SystemDENJOY DENTAL CO.,LTDEKR2025-02-28
04260482991166EndoPilot D-Pack² handpieceSchlumbohm GmbH & Co. KGEKR2025-01-28
04260482991173EndoPilot² expansion DownPack²Schlumbohm GmbH & Co. KGEKR2025-01-28
08809455602164elements IC META SYSTEMS CO., LTD.EKR2024-12-30
08809455602171elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602188elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602195elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602386elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602393elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602409elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
00889813066836Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKR2024-12-12
08800019101581NeedleB& L Biotech, inc.EKR2024-12-03
08800019102168NeedleB& L Biotech, inc.EKR2024-12-03
08800019102175NeedleB& L Biotech, inc.EKR2024-12-03
08800019102182NeedleB& L Biotech, inc.EKR2024-12-03