FDA.reportPublic FDA data

Dental Basics

Primary DI
00850061028204
Brand
Dental Basics
Company
Dental Basics Inc.
Model
PA15
Device description
Disposable Prophy Angles 60° Turn Reciprocating Soft Green
Published
2024-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850061028204PrimaryGS10
20850061028208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061028204008500610282048500610282040850061028204
2085006102820820850061028208

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.

Regulatory Flags#

DUNS number
119194176
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850061028024Dental BasicsBE102024-05-08
00850061028006Dental BasicsBE212024-05-08
00850061028013Dental BasicsBE222024-05-08
00850061028037Dental BasicsBE112024-05-08
00850061028044Dental BasicsBE122024-05-08
00850061028051Dental BasicsBE202024-05-08
00850061028068Dental BasicsMA102024-05-08
00850061028075Dental BasicsMA112024-05-08
00850061028082Dental BasicsMA122024-05-08
00850061028099Dental BasicsMA132024-05-08
00850061028105Dental BasicsMA202024-05-08
00850061028112Dental BasicsMA212024-05-08
00850061028129Dental BasicsMA222024-05-08
00850061028136Dental BasicsAW102024-05-08
00850061028167Dental BasicsPA112024-05-08
00850061028174Dental BasicsPA122024-05-08
00850061028181Dental BasicsPA132024-05-08
00850061028198Dental BasicsPA142024-05-08
00850061028020Dental BasicsBE102024-05-08
20850061028000Dental BasicsBE212024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00302730003123Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003130Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003147Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003154Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29