FDA.reportPublic FDA data

Motor BL

Primary DI
E27663375180
Brand
Motor BL
Company
SIRONA Dental Systems GmbH
Model
6337518
Device description
Motor BL ISO C
Published
2016-09-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27663375180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, remotely-drivenA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
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
true
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
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668234260Primevision 3D675859867585982026-02-13
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810021439532DCI EdgeDCI International, LLCEIA2026-03-23
00810021439549DCI EdgeDCI International, LLCEIA2026-03-23
00810021439556DCI EdgeDCI International, LLCEIA2026-03-23
00810021439563DCI EdgeDCI International, LLCEIA2026-03-23
00810021439570DCI EdgeDCI International, LLCEIA2026-03-23
00810021439587DCI EdgeDCI International, LLCEIA2026-03-23
00810021439594DCI EdgeDCI International, LLCEIA2026-03-23
00810021439600DCI EdgeDCI International, LLCEIA2026-03-23
00810021439617DCI EdgeDCI International, LLCEIA2026-03-23
00810021439518DCI PartsDCI International, LLCEIA2026-03-20
00810021439525DCI PartsDCI International, LLCEIA2026-03-20
00841709122132MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122149MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122156MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122163MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122170MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709121852MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121869MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121876MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121883MidmarkMIDMARK CORPORATIONEIA2026-02-20
10194665008697A-decA-DEC, INC.EIA2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEIA2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEIA2026-02-13
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
07899581342707Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581342844Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343186Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343414Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343599Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343834Water UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31