FDA.reportPublic FDA data

BIS FOOT PEDAL

Primary DI
04719873120291
Brand
BIS FOOT PEDAL
Company
BONART CO., LTD.
Model
FS-30W
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152125000Oral Surgery System and AccessoriesBonart Co., Ltd.2016-08-15DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873120291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873120291047198731202914719873120291

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657263687
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873121854ARTART-P3II PRO2026-04-27
04719873121861ARTART-M3II PRO2026-04-27
04719873121281GT1 Blade Type ElectrodeGT12020-02-27
04719873121298GT2 Small Loop ElectrodeGT22020-02-27
04719873121304GT3 Large Loop ElectrodeGT32020-02-27
04719873121311GT4 Fine Wire ElectrodeGT42020-02-27
04719873121328GT5 Heavy Wire ElectrodeGT52020-02-27
04719873121335GT8 Heavy Ball Electrode (2.38mm)GT82020-02-27
04719873121342GT9 Heavy Ball Electrode (5mm)GT92020-02-27
04719873120048ELECTROSURGERY SYSTEMART-E1 2016-09-20
04719873120161E1 Hand Piece731201612016-09-20
04719873120178E1 Indifference plate EU0004-002R 2016-09-20
04719873120185E1 electrode set (7 tips)731201852016-09-20
04719873120468T1 Diamond shaped electrodeT12016-09-20
04719873120475T2 Small loop electrodeT22016-09-20
04719873120482T3 Large loop electrodeT32016-09-20
04719873120499T4 Fine wire electrodeT4 2016-09-20
04719873120505T5 Heavy wire electrodeT52016-09-20
04719873120512T7 Fine oval loop electrodeT72016-09-20
04719873120529T9 Heavy ball electrodeT9 2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22