FDA.reportPublic FDA data

CA NOVA 1:5L MS

Primary DI
J0071601138001USA1
Brand
CA NOVA 1:5L MS
Company
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Model
1601138-001USA
Device description
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric micromotor.
Published
2025-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J0071601138001USA1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
338234588
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J0071600052001USA1PM 1:1 EXT SPRAY1600052-001USA2025-10-10
J0071600436001USA1PM 1:21600436-001USA2025-10-13
J0071600692001USA1CA 20:1 L MICRO-SERIES1600692-001USA2025-10-10
J0071601136001USA1CA NOVA 1:1L MS1601136-001USA2025-10-10
J0071602490011HOSE MX2 400 GREY_1026461601249-0012026-08-27
J00716009110011CA 8:11600911-0012026-05-22
J00715021220011BOARD DMX3 M Bornier1502122-0012026-02-24
J00715021230011BOARD DMX3 M BtoB1502123-0012026-02-24
J0071600677001USA1MOT MX21600677-001USA2025-10-13
J0071600755001USA1MOT MX-i LED1600755-001USA2025-10-13
J00716000710011Mot MC3 IR1600071-0011600071-0012021-06-17
J00716000730011Mot MC2 IR1600073-0011600073-0012021-06-17
J00716000750011Mot MC2 GT AV1600075-0011600075-0012021-06-17
J00716000770011Mot MC3 LK1600077-0011600077-0012021-06-17
J00716006330011Mot MC2 40 GT IR1600633-0011600633-0012021-06-17
J00716006800011MOT MC31600680-0011600680-0012021-06-17
J0071600386001USA1CA 1:5 L1600386-001USA2025-12-05
J00716012430011XPU MMOTOR CABLE1601243-0012024-04-25
J00716012440011XPU MMOTOR NO LIGHT1601244-0012024-04-24
J00716012460011CABLE I-SURGE LED1601246-0012024-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7022666540StarDentalDENTALEZ, INC.EFB2026-09-18
D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14