FDA.reportPublic FDA data

SIRONiTi APEX

Primary DI
E27661742340
Brand
SIRONiTi APEX
Company
SIRONA Dental Systems GmbH
Model
6174234
Device description
SIRONiTi APEX
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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27661742340PrimaryHIBCC0

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
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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
20686864060943MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
20686864060950MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00850079280069Turbo EdgeHexa DentalEGS2026-01-21
00850079280083Turbo edgeHexa DentalEGS2026-01-21
00008579280083Turbo edgeHexa DentalEGS2026-01-21
00085007928069Turbo EdgeHexa DentalEGS2026-01-21
00850079280076Turbo EdgeHexa DentalEGS2026-01-21
00850079280090Turbo EdgeHexa DentalEGS2026-01-21
00850079280106Turbo EdgeHexa DentalEGS2026-01-21
00850079280113Ergo glideHexa DentalEGS2026-01-21
08404535020892Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020922Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020953Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020984Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535021738ForzaPeter Brasseler Holdings, LLCEGS2026-01-09
00304040194331Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194379Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
D745701120GLH00010Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D950135030SmoothdriveLARES RESEARCHEGS2025-08-25
06971119540548Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540586Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540593Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540982Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540999Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15