Tall Spare Parts, Paltop

GUDID D990KDIHTSP0

Smart Denture Conversions, LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device IDD990KDIHTSP0
NIH Device Record Keyfbc19f3a-8aae-475a-b004-c6aa035c8060
Commercial Distribution StatusIn Commercial Distribution
Brand NameTall Spare Parts, Paltop
Version Model NumberKDIH-TSP
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
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
HIBCCD990KDIHTSP0 [Primary]

FDA Product Code

EJXAnchor, Preformed

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


[D990KDIHTSP0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-29
Device Publish Date2023-05-19

Devices Manufactured by Smart Denture Conversions, LLC

D990SADCK1PK0 - Single Arch Dam Conversion Kit 1PK2025-07-08
D99023BLXOA0 - Omnibut, Straumann BLX2025-05-27
D99023NANPOA0 - Omnibut, Nobel NP2025-05-27
D99023NARPOA0 - Omnibut, Nobel RP2025-05-27
D99023NEOGMOA0 - Omnibut, Neodent GM2025-05-27
D99023ZIH35OA0 - Omnibut, Zimmer Internal Hex 3.52025-05-27
D99023ZIH45OA0 - Omnibut, Zimmer Internal Hex 4.52025-05-27
D99023ZIH57OA0 - Omnibut, Zimmer Internal Hex 5.72025-05-27

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