FDA Registration Active 🇺🇸 United States

AA-20A - AUXILIARY ARM MOBILE DENTAL CART SYSTEM AMC-20 / AMC-25

Reg #: 3017604 · FEI: 3017604 · Expires 2025
Products
1
Proprietary Names
45
Establishment Types
2
Classifications
1

Registration Details

Registration Name
ASEPTICO, INC.
Registration Number
3017604
FEI Number
3017604
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
8333 216th St SE
City
WOODINVILLE
State
WA
ZIP
98072
Country
US

Regulatory Submissions

510(k) Number
K905401

Owner / Operator

Firm Name
ASEPTICO, INC.
Operator Number
3017604
Address
8333 216TH ST., S.E., --
City
Woodinville
State
WA
Postal Code
98072
Country
US

Products

Device Name Product Code
Unit, Operative Dental EIA

Proprietary Names

AA-20A - AUXILIARY ARM MOBILE DENTAL CART SYSTEM AMC-20 / AMC-25 AA-20 - VACUUM RECHARGEABLE PORTABLE ADU-04 - TWO HPCE MINI CONTROL AMC-25 - MOBILE DENTAL CART AMC-25 ADU-12DCE - ASEPTICO TASK FORCE DELUXE AA-12CSB - BRKT ADU-12 CASE LID STANDOFF BRACKET KIT ATC-03CF - COMMAND AIR PORTABLE TRAY 6520-01-446-6263 ADU-17A2 - EXPRESS AIR 2 PORTABLE UNIT AE-200-30 - MOTOR/CABLE ASSY W/LIGHT & H2O ATC-12V2 - CART 4 SHELF ADJUSTABLE WITH AC POWER AA-96EXT - AIR EXTENSION LINE 25FT NWS-8 - WATER SYSTEM AEU-525CF - TRANSPORT III COMMAND FIELD DUAL VOLTAGE UNIT 110/220V AA-26SS - COLLECTOR DRY ORAL CUP STAINLS STEEL W/ STRAINER AE-205-30EXT - MOTOR/CABLE ASSY 30K EXTERNAL WATER ADU-04ST - TWO HPCE MINI CONTROL W/ STAND AMC-25CF-USAF - MOBILE DENTAL CART AMC-25CF-USAF ADU-25 - ENDO-CART BASE MODEL AA-525AMAL - AMALGAM SEPARATOR AEU-525 PORTABLE ADU-20B - COMPRICART II ADU-01C - CASE PORTABLE SUPPLY 5 DRAWER ADU-22 - PORTACART ECONOMY CART AA-21ST - VACUUM HIGH VOLUME AVS INSTALLED ON ADU-04ST AA-100-220 - COMPRESSOR AIRPAC III 220V NWS-7I - WATER SYS SELF-CONT INSTALLED NON-STERILE ADU-07A - HPCE CONTROL AUTOMATIC SYSTEM ECONOMY TA-1 - SYRINGE TIP AUTOCLAVABLE 3-WAY AA-12HVE - ADAPTER HVE ADU-12 TASKFORCE ADU-03ST - THREE WAY AIR-WATER SYRINGE W/ STAND ASC-10L-ACC - ACCESSORY KIT W/SLEEVE FOR LED ASC-10 SCALER ASU-12-230 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 230V AE-240SC-40 - MOTOR/CABLE ASSY AE-240SC-40 W/SHORT CABLE AA-100-110 -COMPRESSOR AIRPAC III 110V ASU-12-110 - AUTOCLAVE PORTABLE PRESTIGE CLASSIC 110V AEU-525CFH - TRANSPORT III WITH HANDPIECES MILITARY 110/220V DUAL VOLTAGE ADU-07 - HPCE CONTROL MANUAL SYSTEM ASC-10-ACC - ACCESSORY KIT ASC-10 SCALER AEU-525 - TRANSPORT III PORTABLE DUAL VOLT UNIT 110/220V AA-25ST - VACUUM SALIVA EJECTOR FOR USE ON ADU-04ST ADU-17X2 - EXPRESS PLUS II PORTABLE UNIT TA-90VC - SYRINGE TA-90 VALVE CARTRIDGE ADU-17A - EXPRESS AIR PORTABLE UNIT AMC-25CF - MOBILE DENTAL CART AMC-25CF ADU-17X - EXPRESS II PORTABLE UNIT AEU-525S - TRANSPORT III W/SCALER DUAL VOLT UNIT 110/220V

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198