PM 1:1 1600383-001

GUDID J00716003830011

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 power tool system handpiece, remotely-driven

Primary Device ID	J00716003830011
NIH Device Record Key	baea0b9d-d6a5-4259-8ed5-ba7916c7c8a9
Commercial Distribution Status	In Commercial Distribution
Brand Name	PM 1:1
Version Model Number	1600383-001
Catalog Number	1600383-001
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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00716003830011 [Primary]

FDA Product Code

EFB	Handpiece, air-powered, dental

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

Moist Heat or Steam Sterilization

[J00716003830011]

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

Devices Manufactured by Bien-Air Dental SA

J00716014110011 - CA Midwest® lmplant 20:1 L	2025-08-22 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716011920011 - WIRELESS FOOTCTRL + DONGLE	2025-02-28 Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
J00717008890011 - Set Console CHIROPRO L US PREMIUM WL	2025-02-28 Sets of Chiropro systems and their dental micromotors, contra-angles or handpieces, and releveant accessories
J00716012350011 - CA PRIMA 1:1	2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716012360011 - CA PRIMA 1:1 L	2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
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

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