Primary Device ID | D691550005200 |
NIH Device Record Key | 515ec70d-b826-46d3-add4-77818b9df2f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AeroPro Cordless Prophy System |
Version Model Number | AP-18-PDPC |
Catalog Number | 5500520 |
Company DUNS | 014789663 |
Company Name | PREMIER DENTAL PRODUCTS COMPANY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 610-239-6000 |
info@premierdentalco.com |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D691550005200 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D691550005200]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-18 |
Device Publish Date | 2020-03-10 |
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00348783005165 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Medium |
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00348783005189 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Extra Coarse |
00348783005196 - Enamel Pro® Prophy Paste | 2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free |