FDA Registration
Active
🇨🇳 China
iBrite Suzhou Technology Co., Ltd
Reg #: 3015491448
·
FEI: 3015491448
·
Expires 2026
Products
18
Proprietary Names
20
Establishment Types
4
Classifications
18
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Registration Details
- Registration Name
- iBrite Suzhou Technology Co., Ltd
- Registration Number
- 3015491448
- FEI Number
- 3015491448
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 51 Zhousidun road
- City
- SUZHOU CITY Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151123
Owner / Operator
- Firm Name
- Pac-Dent Inc.
- Operator Number
- 10056434
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- Nikki Huynh
US Agent
- Business Name
- PAC-DENT, INC.
- Contact Name
- Heather Hang
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 909 8390888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2017-12-29 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2017-12-14 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2017-12-14 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-07-24 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2017-12-14 |
| Collimator, X-Ray | EHB | Class 1 | Dental | No | 2017-12-11 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2017-12-14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2017-12-21 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2017-12-11 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2017-12-14 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2017-12-11 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2017-12-14 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2017-12-21 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2017-12-08 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2017-12-21 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-12-08 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2017-12-21 |
Proprietary Names
iMatrix Clear
Pac-Dent SG
AntiSplatr Disposable Prophy Angles
131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk
131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk
131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk
131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk
131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk
131120 EzAim Individually Cut Adhesive Sensor Holder Posterior Yellow, 50/pk
131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk
131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk
131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk
131120 EzAim ComforTab Adhesive Sensor Holder Posterior Yellow, 50/pk
Pac-Dent Disposable Tray, Tooth Whitening
PJ-01 ProJect Composite Dispensing Gun
Air Techniques
Pac-Dent Barrier Sleeve, Cover It Barrier Film
UNIVERSAL CURING LIGHT SHIELD
PSP Barrier Envelopes
Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device