FDA.reportPublic FDA data

MicroP Dental

Primary DI
04719880151080
Brand
MicroP Dental
Company
MICROP TECHNOLOGY (TAIWAN) INC.
Model
A008
Device description
Dental High-speed Handpiece
Published
2020-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K173943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173943000Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc.2018-07-24EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719880151080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719880151080047198801510804719880151080

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
656026072
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719880152018MicroP DentalAC1002020-12-21
04719880152025MicroP DentalAC2002020-12-21
04719880152032MicroP DentalAC2012020-12-21
04719880152049MicroP DentalAC3002020-12-21
04719880152056MicroP DentalAC3012020-12-21
04719880152063MicroP DentalAC4002020-12-21
04719880152070MicroP DentalAC4012020-12-21
04719880152087MicroP DentalAC5002020-12-21
04719880152094MicroP DentalAC5012020-12-21
04719880152100MicroP DentalAC6002020-12-21
04719880152117MicroP DentalAC6012020-12-21
04719880152124MicroP DentalAC6022020-12-21
04719880151011MicroP DentalA0012020-08-01
04719880151028MicroP DentalA0022020-08-01
04719880151035MicroP DentalA0032020-08-01
04719880151042MicroP DentalA0042020-08-01
04719880151059MicroP DentalA0052020-08-01
04719880151066MicroP DentalA0062020-08-01
04719880151073MicroP DentalA0072020-08-01
04719880151097MicroP DentalA0092020-08-01

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Primary DI, Brand, Company table
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