CA 1:2.5 L MS 1601164-001

GUDID J00716011640011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed

Bien-Air Dental SA

Dental laboratory drilling system handpiece
Primary Device IDJ00716011640011
NIH Device Record Key1dc03bfa-2e51-43ed-87d7-b805d7286f46
Commercial Distribution StatusIn Commercial Distribution
Brand NameCA 1:2.5 L MS
Version Model Number1601164-001
Catalog Number1601164-001
Company DUNS480082080
Company NameBien-Air Dental SA
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
HIBCCJ00716011640011 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


[J00716011640011]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-25
Device Publish Date2023-07-17

On-Brand Devices [CA 1:2.5 L MS]

J00716010550011CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or e
J00716011640011CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or e

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