Rapid Arch Large Round Lower 1PK, Shade BL2

GUDID D990RALRL1PKBL20

Smart Denture Conversions, LLC

Dental impression tray, single-use
Primary Device IDD990RALRL1PKBL20
NIH Device Record Keya23163b7-dbb9-4167-b3e9-bf20825ed583
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapid Arch Large Round Lower 1PK, Shade BL2
Version Model NumberRA-LRL1PK-BL2
Company DUNS010613514
Company NameSmart Denture Conversions, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com
Phone8555500707
Emailcontact@smartdentureconversions.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD990RALRL1PKBL20 [Primary]

FDA Product Code

EHYTray, Impression, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-11
Device Publish Date2024-11-01

On-Brand Devices [Rapid Arch Large Round Lower 1PK, Shade BL2]

D990RAMRL1PKBL20RA-LRL1PK-BL2
D990RALRL1PKBL20RA-LRL1PK-BL2

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