FDA Registration
Active
🇺🇸 United States
A130000000022 - Calamus Dual
Reg #: 3017604
·
FEI: 3017604
·
Expires 2025
Products
1
Proprietary Names
34
Establishment Types
1
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
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2013-08-12 |
Proprietary Names
A130000000022 - Calamus Dual
BCPGSIQ000RPC - Gutta-Smart Remote Power Cord
BNSGSIQA0020G - Gutta-Smart GP Crtg 20G 10-pack
BSPGSIQ000001 - Gutta-Smart Charger Base
B00GSIQ100SML - Gutta-Smart Electric Heat Plugger, Small
BNSGSIQA0023G - Gutta-Smart GP Crtg 23G 10-pack
A122000000000 - Calamus Dual Gutta-Percha Cartridges 23G
BCPGSIQ000FLO - Gutta-Smart Flow Handpiece
A130000000000 - Calamus Dual
BCPGSIQ000HES - Gutta-Smart Flow Heater
A115000000000 - Calamus thermal response
BSPGSIQ000003 - Gutta-Smart Charger Feet
BSPGSIQ000002 - Gutta-Smart Charger top with LCD
A120800000000 - Calamus Dual Hand Piece Cleaning Brush
BNSGSIQA0025G - Gutta-Smart GP Crtg 25G 10-pack
A111000000000 - Calamus Heated Plugger - Small
A130000000033 - Calamus Dual
B00GSIQ100LRG - Gutta-Smart Electric Heat Plugger, Large
A130000000002 - Calamus Dual
BCPGSIQ000PAK - Gutta Smart Pack Handpiece
B00GSIQ100000 - Gutta-Smart Thermal Response Tip
A130000000026 - Calamus Dual
A121000000000 - Calamus Dual Gutta-Percha Cartridges 20G
B00GSIQ100MED - Gutta-Smart Electric Heat Plugger, Medium
BSPGSIQ000004 - Fastener screw
A112000000000 - Calamus Heated Plugger - Medium
B00GSIQ000BAS - Gutta-Smart Base Station
A113000000000 - Calamus Heated Plugger - Large
B00GSIQ000KIT - Gutta-Smart Cordless Obturation System
BCPGSIQ000CAP - Gutta-Smart Cleaning Caps
A120600000000 - Replacement Cartridge Nut
A120900000000 - Calamus Hand Piece Heat Shield
A120700000000 - Cartridge Needle Bending Tool
BCPGSIQ000BET - Gutta-Smart Cannula Bender
Establishment Types
Manufacture Medical Device