FDA.reportPublic FDA data

X-Smart Pro

Primary DI
E27667790160
Brand
X-Smart Pro
Company
SIRONA Dental Systems GmbH
Model
6779016
Catalog number
6779016
Device description
X-Smart Pro+
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKXHandpiece, direct drive, ac-powered
LQYLocator, root apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
LQYLocator, Root ApexUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27667790160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
340306351
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668234260Primevision 3D682342667585982026-02-13
E27668234830Primevision 3D68234832026-04-30
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27660437020IMPLANT 20:160437022016-09-10
E27668082030Primescan 268082032025-11-21
E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28
E27668082450Primescan 2680824568082452025-10-23
E27668534800CAD/CAM Software68534802025-08-19
E27660471250Motor BL 60471252016-09-10
E27663375180Motor BL ISO C63375182016-09-10
E27663082950TiBase63 08 29563 08 2952015-10-17
E27668665240Midwest68665242025-10-17
E27668053651Primescan 2 Multiuse Sleeve680536568053652025-09-16
E27668558402Primescan 2685584068558402025-08-20
E27668020400Primescan 2680204068020402025-05-16
E27665716860SiroLaser65716862025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1001309252002Apex File Grip (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
D1001309253002Apex Lip hook (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08033837938316CEFLACEFLA SOCIETA' COOPERATIVALQY2026-03-31
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008444A-decA-DEC, INC.LQY2026-02-19
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008475A-decA-DEC, INC.LQY2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.LQY2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.LQY2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23