Maint Lubrifluid (Single Can) 1600064-001

GUDID J00716000640011

Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments

Bien-Air Dental SA

Surgical instrument maintenance lubricant

Primary Device ID	J00716000640011
NIH Device Record Key	a4a5c892-9749-4033-9b70-74a9c4c58d58
Commercial Distribution Status	In Commercial Distribution
Brand Name	Maint Lubrifluid (Single Can)
Version Model Number	1600064-001
Catalog Number	1600064-001
Company DUNS	480082080
Company Name	Bien-Air Dental SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com
Phone	+1 949-477-6050
Email	ba-usa@bienair.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00716000640011 [Primary]
HIBCC	J00716000640061 [Package] Package: Box 6 Cans [6 Units] In Commercial Distribution

FDA Product Code

EFB	Handpiece, air-powered, dental

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

[J00716000640011]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-06-25
Device Publish Date	2021-06-17

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J00716012370011 - CA PRIMA 1:1 L MS	2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716012670011 - CA PRIMA 1:121	2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716014080011 - PM CA 20:1 L RO 104936	2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716014090011 - PM PM 1:1 RO sp. ext. 104936	2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716012420011 - XPU MMOTOR LIGHT	2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00716012450011 - I-SURGER LED	2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic

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