FDA.reportPublic FDA data

PRO AS-PAX SU B2 KIT

Primary DI
04560264504370
Brand
PRO AS-PAX SU B2 KIT
Company
NAKANISHI INC.
Model
PRO AS-PAX SU B2 KIT
Published
2016-09-16
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

Product Codes#

Code, Name table
CodeName
ELCScaler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264504370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264504370045602645043704560264504370

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpieceA holder for a detachable tip that functions as part of a pneumatic dental scaling/debridement system, designed to use compressed air to generate a vibrating action at the tip to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. Water is also fed through the handpiece and attached tip to assist in the process. It is typically designed with a standard 2-, 3-, or 4-hole connector utilizing the same connection to existing air-driven handpiece tubing and the water spray for lavage. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
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
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22
04589551388929VA170LUX-SCVA170LUX-SC2026-02-13
04589551388936VA170-SCVA170-SC2026-02-13
04589551388981Potentiometer SetPotentiometer Set2026-02-13
04589551389452VariosG162026-02-13
04589551383900VariosScaling G16 Pack2026-02-13
04589551389476Perio Kit APerio Kit A2026-02-13
04589551389483VA170VA1702026-02-13
04560264577763VA2-LUX-HP TiVA2-LUX-HP Ti2026-02-13
04589551387168Tip Cover LTip Cover L2026-01-21
04589551387151Tip Cover STip Cover S2026-01-21
04589551382828E TIP WRENCHE TIP WRENCH2026-01-21
04589551387144VariosCR-12026-01-21
04560264579958CLA-10CLA-102026-01-21
045895513889743 Mode Select Switch3 Mode Select Switch2026-01-21
04589551383863VariosG12022-12-13
04589551383870VariosG42022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
07613353180089Instruments A P PSE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353180096Instruments PS PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353336837Instruments PSR PSLE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-16
04589551388929VA170LUX-SCNAKANISHI INC.ELC2026-02-13
04589551388936VA170-SCNAKANISHI INC.ELC2026-02-13
04589551388981Potentiometer SetNAKANISHI INC.ELC2026-02-13
04589551389452VariosNAKANISHI INC.ELC2026-02-13
04589551383900VariosNAKANISHI INC.ELC2026-02-13
04589551389476Perio Kit ANAKANISHI INC.ELC2026-02-13
04589551389483VA170NAKANISHI INC.ELC2026-02-13
04560264577763VA2-LUX-HP TiNAKANISHI INC.ELC2026-02-13
04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
04589551387144VariosNAKANISHI INC.ELC2026-01-21
04560264579958CLA-10NAKANISHI INC.ELC2026-01-21
045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21