Press on Cap 6PK, TiLobe (Quad Drive)

GUDID D990KDTLPOC6PK0

Smart Denture Conversions, LLC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device IDD990KDTLPOC6PK0
NIH Device Record Key7c3b4b8a-9e23-4bc6-add7-cd8f6ff3936a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePress on Cap 6PK, TiLobe (Quad Drive)
Version Model NumberKDTL-POC6PK
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

Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com
Phone855-550-0707
EmailContact@SmartDentureConversions.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD990KDTLPOC6PK0 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


[D990KDTLPOC6PK0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-14
Device Publish Date2022-12-26

Devices Manufactured by Smart Denture Conversions, LLC

D990ZVPOC10PK0 - Press on Cap 10PK, ZimVie2023-11-30
D990ZVLPPSK0 - Premium Starter Kit, Low Profile2023-11-29
D990ZVLPRK0 - Recharge Kit w/ Tall Spare Parts, Low Profile2023-11-29
D990ZVLPRKPOC0 - Recharge Kit w/ POC, Low Profile2023-11-29
D990ZVLPSFA10PKDK0 - Separable Fastener Assembly 10PK - Drill Kit Included, Low Profile2023-11-29
D990ZVLPSTB10PK0 - Standard TiBase 10PK, Low Profile2023-11-29
D990ZVLPTKP0 - Training Kit Parts, Low Profile2023-11-29
D990ZVLPTTB10PK0 - Tall TiBase 10PK, Low Profile2023-11-29

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