FDA.reportPublic FDA data

ESA MW Disposable Prophy Angle Firm Cup Box 100

Primary DI
D0243300023
Brand
ESA MW Disposable Prophy Angle Firm Cup Box 100
Company
Preventech
Model
3300023
Catalog number
3300023
Device description
ESA MW Disposable Prophy Angle Firm Cup Box of 100 single use prophy angle for dental prophylaxis procedures
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994024000EXTENDED STRAIGHT ATTACHMENTTeam Technologies, Inc.2000-02-03EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0243300023PrimaryHIBCC0
D02433000233Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7048492416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D024772105VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 357721057721052016-10-05
D024772113VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 1007721137721132016-10-05
D024772115VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 1007721157721152016-10-05
D024772145VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 357721457721452016-10-05
D024772153VELLAmini 5% Sodium Fluoride Varnish Caramel Box 1007721537721532016-10-05
D024772155VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 1007721557721552016-10-05
D024772215VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 357722157722152016-10-05
D024772225VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 357722257722252016-10-05
D024772235VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 1007722357722352016-10-05
D024772245VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 1007722457722452016-10-05
D024772275VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 357722757722752016-10-05
D024772285VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 1007722857722852016-10-05
D024772103VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 357721037721032016-10-05
D024772143VELLAmini 5% Sodium Fluoride Varnish Caramel Box 357721437721432016-10-05
D024772213VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 357722137722132016-10-05
D024772223VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 357722237722232016-10-05
D024772233VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 1007722337722332016-10-05
D024772243VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 1007722437722432016-10-05
D024772273VELLAmini 5% Sodium Fluoride Varnish Melon Box 357722737722732016-10-05
D024772283VELLAmini 5% Sodium Fluoride Varnish Melon Box 1007722837722832016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29