Water Flosser

GUDID 00850007728168

Water Flosser removes 99% of the plaque between teeth and below the gumline

ACCESS DENTAL LAB, LLC

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Primary Device ID00850007728168
NIH Device Record Keycc996c56-3b35-4c1f-8ed6-9d6246b6b99a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWater Flosser
Version Model Number100-0366
Company DUNS054012763
Company NameACCESS DENTAL LAB, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com
Phone901-361-0576
Emailjoe.miller@accessdentallab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007728168 [Primary]

FDA Product Code

EFSUnit, Oral Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-27
Device Publish Date2019-08-19

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00850007728366 - Impression Tray XSM2023-02-27 Impression Tray Extra Small
00850007728373 - IMPRESSION TRAY SM2023-02-27 IMPRESSION TRAY SMALL SIZE
00850007728380 - IMPRESSION TRAY MED2023-02-27 IMPRESSION TRAY MEDIUM SIZE
00850007728397 - IMPRESSION TRAY LRG2023-02-27 IMPRESSION TRAY LARGE SIZE
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