FDA.reportPublic FDA data

MIDWEST®

Primary DI
D00390702PK031
Brand
MIDWEST®
Company
Dentsply Professional
Model
90702PK03
Device description
MIDWEST® RDH Freedom® Cordless Prophy System, Premium System - Pink. Contains: 3 Sheaths, 200 NUPRO Freedom® Disposable Prophy Angles and 1 Disposa-Shield ® Trial Pack.
Published
2016-11-11
Public version status
Update
Distribution status
Not 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
PEMDental barriers and sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00390702PK031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool non-rotary polishing endpieceAn oscillating, sagittal, or reciprocating dental instrument designed to be attached to a dedicated dental power tool handpiece to perform a specific final mechanical function (e.g., polishing, contouring, finishing) during an orthodontic procedure (e.g., interproximal reduction). It is a metallic flat endpiece in the form of a blade; some types may be diamond coated. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Atmospheric limitations 500 to 1060 hPa.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
144140845
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0013032800Ceramco 33032803032802026-02-20
D0013031901Ceramco 33031903031902024-10-02
D0013032801Ceramco 33032803032802024-10-02
D0013034001Ceramco 33034003034002024-10-02
D0013034601Ceramco 33034603034602024-10-02
D0013035601Ceramco 33035603035602024-10-03
D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
D0013038401Ceramco 33038403038402024-10-03
D0013039201Ceramco 33039203039202024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02
D0013051211Ceramco 33051213051212024-10-03
D0013051321Ceramco 33051323051322024-10-02
D0013051331Ceramco 33051333051332024-10-02
D0013051371Ceramco 33051373051372024-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02