FDA Registration
Active
🇺🇸 United States
B00GS1Q100SML Gutta-Smart Electric Heat Plugger, Small
Reg #: 3017604
·
FEI: 3017604
·
Expires 2025
Products
1
Proprietary Names
28
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 | 2019-09-09 |
Proprietary Names
B00GS1Q100SML Gutta-Smart Electric Heat Plugger, Small
B00GS1Q100000 Gutta-Smart Thermal Reponse Tip
B00GS1Q100HES Gutta-Smart Heating Element
B00GS1Q00LRG Gutta-Smart Electric Heat Plugger, Large
B00GS1Q100MED Gutta-Smart Electric Heat Plugger, Medium
A130000000026 - Calamus Dual - JAP
A121000000000 - Calamus Dual Gutta-Percha Cartridges 20G
A115000000000 - Calamus thermal response
A120900000000 - Calamus Hand Piece Heat Shield
A113000000000 - Calamus Heated Plugger - Large
V040547000040 - Plugger root canal endodontic Beefill Heat Plugger Standard 40/3
V040548000000 - Dental Hand Instrument-Beefill Thermal Response Tip
A130000000000 - Calamus Dual - EUR
A130000000022 - Calamus Dual - AUS
V040532053080 - GUTTA PERCHA-Beefill Cartridge 20G
A120800000000 - Calamus Dual Hand Piece Cleaning Brush
A120600000000 - Replacement Cartridge Nut
V040541000000 - Dental Hand Instrument-Beefill 2in1 (Obturation Device)
A112000000000 - Calamus Heated Plugger - Medium
A120700000000 - Cartridge Needle Bending Tool
V040532053060 - GUTTA PERCHA-Beefill Cartridge 23G
A111000000000 - Calamus Heated Plugger - Small
A130000000002 - Calamus Dual - CH
A122000000000 - Calamus Dual Gutta-Percha Cartridges 23G
A130000000033 - Calamus Dual - UK
V040546000050 - Plugger root canal endodontic Beefill Heat Plugger Soft 50/5
V040532053045 - GUTTA PERCHA-Beefill Cartridge 25G
V040546000060 - Plugger root canal endodontic Beefill Heat Plugger Soft 60/6
Establishment Types
Manufacture Device in the United States for Export Only