FDA Registration
Active
🇺🇸 United States
Pascal International, Inc.
Reg #: 3011632
·
FEI: 3011632
·
Expires 2026
Products
17
Proprietary Names
82
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- Pascal International, Inc.
- Registration Number
- 3011632
- FEI Number
- 3011632
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2929 Northup Way
- City
- Bellevue
- State
- WA
- ZIP
- 98004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030488
Owner / Operator
- Firm Name
- Pascal International
- Operator Number
- 3011632
- Address
- 2929 Northup Way
- City
- Bellevue
- State
- WA
- Postal Code
- 98004
- Country
- US
- Correspondent
- Elizabeth Williams
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2021-04-13 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 1992-07-28 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1992-07-28 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 1983-09-27 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2008-06-10 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 1992-07-28 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2001-04-29 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2006-08-21 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-10-13 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2007-11-28 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2007-11-28 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2009-10-28 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 1992-07-28 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2024-05-14 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2019-01-24 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2004-08-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 1992-07-28 |
Proprietary Names
Retrax System Mirror
OCCLUDE
HYDENT
HYDENT STICKS
C-IPC/Off Angle Composite Placing
R-101 PACKING INSTRUMENT
R-11
R-11 PACKING INSTRUMENT
101
R-55
C-IPC Composite Placing Instrument
, R-50
C-Plugger Composite Placing Instrum
Get Packed
Kois KR Series
BK Probe
Contra Angle
Prophy Angle
PDP Foam Fluoride Tray
Juciy Tray
Juicy Tray Animal Pals
PROMARK FORCEPS
Retrax Tweezer
NanoByte
R-50 Retraction Packing Instrument
Retrax Cord Cutter
Guyer 7A Retraction Packing Instr
Black Retrax System R-101
Black Retrax System R-11
PT-55 Retraction Packing Instrument
Black Retrax System R-55
Retrax Mirror
Pick Pack
Black Retrax System R-50
R-EX Retraction Explorer
Retrax System Locking Tweezer
MicroGrip Pro Multi-use Instrument
R-55A Retraction Packing Instrument
R-101 Retraction Packing Instrument
R-11 Retraction Packing Instrument
Pick Pack Forte
R-55 Retraction Packing Instrument
Retrax System Tweezer
Retrax FS Solution
KNITTRAX
Racellet Pellets
Gel Cord Clear
SILTRAX AS
Stat Gel
RACORD Plus
PASCORD
Retrax Gel AS Clear
Epidri Pellets
Retrax AC Solution
SILTRAX EPI
SILTRAX PLAIN
Retrax Pellets
RACORD
Retrax Gel FS
Gel Cord
RETRAX
Retrax Gel AS
RACORD TWO
SILTRAX PLUS
RETRAX PELLETS
RETRAX SOLUTION
ProPak
Citrizyme
Fluorilaq
Fluorilaq Squeeze
Fluorilaq Unit Dose
Banicide Advanced
Fluorilaq Varnish Brush
PDP Applicator
MicroBend Applicator
ORATIP
Get Sculpted Wax Carving Set
Isolator
Mini Isolator
RADENT PROPHY PASTE
Radent Prophy Paste - Non Fluoride
RAFORMER
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device