FDA Registration
Active
🇺🇸 United States
PRACTICON, INC.
Reg #: 1051614
·
FEI: 1051614
·
Expires 2026
Products
37
Proprietary Names
112
Establishment Types
3
Classifications
37
Registration Details
- Registration Name
- PRACTICON, INC.
- Registration Number
- 1051614
- FEI Number
- 1051614
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1112 SUGG PKWY.
- City
- Greenville
- State
- NC
- ZIP
- 27834
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151123
Owner / Operator
- Firm Name
- PRACTICON, INC.
- Operator Number
- 1051614
- Address
- 1112 SUGG PKWY., --
- City
- Greenville
- State
- NC
- Postal Code
- 27834
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2020-08-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-06-09 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2018-05-11 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2016-01-14 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2019-12-30 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2015-06-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-02-03 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-02-03 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2018-10-29 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2023-08-18 |
| Splint, Endodontic Stabilizing | ELS | Class 2 | Dental | No | 2018-08-03 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-12-16 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2022-11-03 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2017-07-11 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2006-12-07 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2011-07-07 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2021-01-08 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2006-12-07 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2008-04-09 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2017-07-11 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2015-06-05 |
| Floss, Dental | JES | Class 1 | Dental | No | 2007-01-11 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2003-10-06 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2022-11-03 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2007-05-18 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2023-06-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2022-07-22 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2017-07-11 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2011-05-25 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2013-11-25 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2024-07-25 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-07-25 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2024-07-25 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2023-06-09 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2019-07-08 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2017-07-11 |
Proprietary Names
TTL Easy Size Loupes
Practifilm Barrier Cling Sheets
Acu-Tip Electrosurgical Cauterizing Instrument
Lumindex 3
BFC UNIT DOSE SYRINGE
BFC3 Powered Impression Gun
HP Mixing Tips
Ribbon Intraoral Tips
Bliss Face Masks
Giggle Monster Face Masks
Practivalu Toothbrush
NiceTouch Toothbrush
SmileGoods Toothbrush
Cool Cassette 2 Instrument Tray
BurSafe Bur Holder
Cool Cassette 1
Cool Cassette 2 Compartment Tray
Bite DX
Roetzer Posterior Packer Sculptor (PPS) Instrument
Compo-Dots
Compo-Dot Angles
EndoBand Cushions
Disposable Probe/Shepherd's Hook
HAHN 360 PDL Extractor Instrument
Disposable Exam Packs
Pike Anesthetic Syringe
PRACTICON LIGATURE TIES
GlasSpan Dental Fiber
Standard Non-Woven Sponge
Premium Non-Woven Sponge
Patient Relief Wax
QUIKSheath Barriers
SmileGoods Tongue Cleaners
Plastic Tongue Cleaners
Color Splash Saliva Ejectors
Practicon Colorful HVE Tips
Mirro-Vac
VacGuard HVE Screen Tips
ColorFlex Saliva Ejectors
ECOtip HVE Tips
Angle-Ease
Color Tip Saliva Ejectors
LockOn S/E Valve Tips
WhisperSafe HVE Tips
Dispos-Evac HVE Tip
Dispos-Evac Aspirators
Mirro-Vac 2
HVEZ Hose Adapter
Lock-on Saliva Ejector Valves
Multi-Tips HVE Tips
Total-Comfort ColorFlex Soft Tip Aspirators
Rainbow Saliva Ejectors
Lock-On Saliva Ejector Valve
Max-Vac Evacuator Tips
Lock-On HVE Hose Adapter
PractiTip A-W Syringe Tips
Practicon Rainbow Disposable A/W Syringe Tips
Practicon Onyx Disposable A/W Syinge Tips
Practicon Clear Disposable A/W Syringe Tips
Smilegoods Sonic Toothbrush
Disposable Mouth Mirror
Mirror Cotton Holders
Nice Touch Mouth Mirrors
Practicon Versagrip Mouth Mirrors
Practicon Classic Disposable Mouth Mirrors
Practicon Vibrant Disposable Mouth Mirrors
Practicon Fog-Free Photo Mirror Kit
Lumindex 3 Barrier Sleeves
PlateMates PSP Protectors
Soft-Prop
E-Prop
FlexiProp Reusable Mouth Prop
Disposable E-Prop
FlosSeas
Floss Hands
SmileGoods Dental Floss
Mobile Floss
Indifloss
Giraffe Flossers
Floss Holders
Mint Floss Picks
SDFLosser
Smilegoods Floss Threaders
Mobile Floss 2
SmileGoods 3-in-1 Flossers
PractiShield
Practicon 33G Dental Needle
SmileGoods Aligner Chewies
Smilegoods Aligner Remover
Smilegoods Right-Bite Aligner Seaters
Y Type Cheek Retractor
C Type Winged Cheek Retractor
C Type Cheek Retractor
Lip Retractor
GP Cut Replacement Tips
GP Cut Gutta Percha Cutter
Dr. Shwartzs Cap Trap Retainers
SmileGoods PikPak Interproximal Cleaners
Micro Tray
Practicon Autoclavable Impression Tray
Disposable Edentulous Trays
ECOsply Biodegradable Impression Trays
Paraband
Practicon Sterilization Pouches
PRACTIFILM BARRIER FILM
Spot-On 2 LED Headlight
Spot-on Plus Headlight
ADDaSEAL RE Adhesive Face Mask Strips
Practicon Face Shields
ADDaSEAL Adhesive Face Mask Strips
Clear-All Face Shield
I-Beam Fluoride Tray
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device