FDA.reportPublic FDA data

Dental Basics

Primary DI
00850061028143
Brand
Dental Basics
Company
Dental Basics Inc.
Model
AM10
Device description
Prophy Angle Air Motor, Air Motor + 3 Nose Cones
Published
2024-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170261000Premium Plus Prophy Air MotorPremium Plus International Limited2017-10-19EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061028143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061028143008500610281438500610281430850061028143

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, pneumaticA hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119194176
Device count
1
Serial number
true
Manufacturing date on label
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
00850061028204Dental BasicsPA152024-05-08
00850061028020Dental BasicsBE102024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7022666540StarDentalDENTALEZ, INC.EFB2026-09-18
D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
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D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
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