Gingival Scan Body 10PK

GUDID D990GSB10PK0

Smart Denture Conversions, LLC

Dental implant abutment analog, scanning
Primary Device IDD990GSB10PK0
NIH Device Record Key4560451e-dcca-49fc-a180-9d502b419a5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGingival Scan Body 10PK
Version Model NumberGSB10PK
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD990GSB10PK0 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


[D990GSB10PK0]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

Devices Manufactured by Smart Denture Conversions, LLC

D990CC10PK0 - Comfort Cap 10PK2025-02-28
D990HC10PK0 - Healing Cap 10PK2025-02-28
D990OS10PK0 - Orientation Screw 10PK2025-02-28
D990CA10PK0 - Cementation Aid 10PK2024-11-11
D990CTB10PK0 - Cementable TiBase 10PK2024-11-11
D990GSB10PK0 - Gingival Scan Body 10PK2024-11-11
D990GSB10PK0 - Gingival Scan Body 10PK2024-11-11
D990HSG10PK0 - Horizontal Scan Gauge 10PK2024-11-11
D990OTICMU5PK0 - Open Tray Impression Coping Multi-Unit 5PK2024-11-11

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.