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510(k) K941189

Device
DISPOSABLE PROPHYLAXIS ANGLE
Applicant
TEAM TECHNOLOGIES, INC.
510(k) number
K941189
Product code
EGS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-16
Date received
1994-03-14
Regulation
872.4200
Classification name
Handpiece, Contra- And Right-angle Attachment, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
R WATTON
Address
5949 Commerce Blvd. Morristown TN US 37814 37814

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EGS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited2025-09-15
K240950Disposable Prophy AnglePacific Care Limited2025-05-28
K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division2024-09-19
K230106General Cutting StraightNakanishi, Inc.2023-05-24
K222518FX ContraNakanishi, Inc.2022-11-17
K220874Smooth Drive contra angle and straight handpiecesLares Research2022-11-07
K220346Lotus Prophy AngleAjk Engineering, Inc.2022-11-07
K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd.2022-07-29
K213139SURGmatic S15 L ProKavo Dental GmbH2021-12-21
K202960General Cutting Contra HandpieceNakanishi, Inc.2020-10-27
K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd.2019-11-26
K182999General Cutting Contra HandpieceNakanishi, Inc.2019-04-16
K181129STRONG Dental HandpiecesSaeshin Precision Co., Ltd.2019-01-31
K171436STRONG Dental HandpiecesSaeshin Precision Co., Ltd.2018-01-05
K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)Bonart Co., Ltd.2017-07-18

Legacy Summary#

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FDA Review#

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