AeroPro Cordless Prophy System 5500520

GUDID D691550005200

AeroPro Sterilizable Outer Sheath

PREMIER DENTAL PRODUCTS COMPANY

Dental power tool system handpiece, battery-powered
Primary Device IDD691550005200
NIH Device Record Key515ec70d-b826-46d3-add4-77818b9df2f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeroPro Cordless Prophy System
Version Model NumberAP-18-PDPC
Catalog Number5500520
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-239-6000
Emailinfo@premierdentalco.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD691550005200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D691550005200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

Devices Manufactured by PREMIER DENTAL PRODUCTS COMPANY

00348783012989 - Enamel Pro® Prophy Paste2025-07-24 Enamel Pro® Prophy Paste Grape-Medium
00348783005134 - RC-Prep2025-07-17 RC PREP PLASTIC 9G SYR TIP REFILL (50)
00348783005141 - RC-Prep2025-07-17 RC-PREP 3CC SYRINGE TIP REFILL (50)
00348783005158 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Fine (Box of 200)
00348783005165 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Medium
00348783005172 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse
00348783005189 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Extra Coarse
00348783005196 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.