FDA.report

T1 CLASSIC

Primary DI
E27658992780
Brand
T1 CLASSIC
Company
SIRONA Dental Systems GmbH
Model
5899278
Device description
T1 CLASSIC PROPHY
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

Related Records

Contact Domains

Product Codes

CodeName
EFAHandpiece, Belt And/Or Gear Driven, Dental
EFBHandpiece, Air-Powered, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EFAHandpiece, Belt And/Or Gear Driven, DentalDental1
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E27658992780PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
J00716014150011smartIPRBien-Air Dental SAEFB2026-03-20
008171690239203D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
008171690239373D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
00817169028017Hydrolux by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFB2026-03-11
04548213060153STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060160STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213060177STERLINGJ.MORITA MFG.CORP.EFA2026-02-20
04548213057320TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057337TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057344TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057368TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
04548213057375TWINPOWER TURBINE 4HJ.MORITA MFG.CORP.EFA2026-02-03
J00716014030011PM OSCILLATING IPRBien-Air Dental SAEFB2026-01-23
03663394482325HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-12-17
03609820101286BUSE PERIO MAINT AIR N GO EASYSATELECEFB2025-12-10
J0071600386001USA1CA 1:5 LBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-12-05
J021020835000MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021063951001MCA-QC-RMW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J021064226001MCA-QC-ISOW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600677001USA1MOT MX2BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
J0071600755001USA1MOT MX-i LEDBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2025-10-13
04589551393367PANA SPRAY PlusNAKANISHI INC.EFB2025-09-24
D178F160Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC164K1Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC165K1Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
D178QC170Flight Dental SystemsFlight Dental Systems USA Inc.EFB2025-08-29
03663394865371HAND-PIECES / CONTRE-ANGLESETABLISSEMENTS ANTHOGYREFA2025-08-20
J00716014110011CA Midwest® lmplant 20:1 LBien-Air Dental SAEFB2025-08-14
00810021437835DCI EdgeDCI International, LLCEFB2025-08-11
06971119540036Dental Low-Speed Turbine HandpieceGuangdong JINME Medical Technology Co., Ltd.EFB2025-07-15