Denture, Surgical guide

GUDID 08936214221370

ACESO DENTAL LABORATORY COMPANY LIMITED

Custom-made orthopaedic/craniofacial surgical guide
Primary Device ID08936214221370
NIH Device Record Keyebef652d-6328-40f4-8664-d78fbe8e4aae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDenture, Surgical guide
Version Model Number136
Company DUNS673251143
Company NameACESO DENTAL LABORATORY COMPANY LIMITED
Device Count2
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108936214221363 [Primary]
GS108936214221370 [Unit of Use]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


[08936214221370]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-25
Device Publish Date2022-10-17

Devices Manufactured by ACESO DENTAL LABORATORY COMPANY LIMITED

08936214229994 - Denture, Restoration Surgical guide2023-02-28
08936214223312 - Denture, Restoration 2022-10-28
08936214223336 - Restoration2022-10-28
08936214223350 - Denture, Restoration 2022-10-28
08936214223374 - Denture, Restoration 2022-10-28
08936214223398 - Restoration2022-10-28
08936214224012 - Denture, Restoration 2022-10-28
08936214224036 - Denture, Restoration 2022-10-28

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