HEALING ABUTMENT SLIM 4035-5HA (SLIM)

GUDID D78540355HASLIM0

(SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM LENGTH

OCO BIOMEDICAL INC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device IDD78540355HASLIM0
NIH Device Record Keya1b2da4a-713b-4cb5-a2ff-61e6945f6947
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALING ABUTMENT SLIM
Version Model Number4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM
Catalog Number4035-5HA (SLIM)
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
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
HIBCCD78540355HASLIM0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


[D78540355HASLIM0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

On-Brand Devices [HEALING ABUTMENT SLIM]

D78540355HASLIM0(SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 5MM LENGTH
D78540353HASLIM0(SLIM) 4.0mm ENGAGE HEALING ABUTMENT 3.5MM PLATFORM, 3MM LENGTH
D78550455HASLIM0(SLIM) 5.0MM ENGAGE HEALING ABUTMENT 4.5MM PLATFORM, 5MM LENGTH
D78550453HASLIM0(SLIM) 5.0MM ENGAGE HEALING ABUTMENT 4.5MM PLATFORM, 3MM LENGTH
D78560575HASLIM0(SLIM) 6.0MM ENGAGE HEALING ABUTMENT 5.7MM PLATFORM, 5MM LENGTH
D78560573HASLIM0(SLIM) 6.0MM ENGAGE HEALING ABUTMENT 5.7MM PLATFORM, 3MM LENGTH

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