Ibrite Suzhou Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 18 device types.
iBrite Suzhou Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Needle, Dental, Cup, Prophylaxis and 16 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | iBrite Suzhou Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015491448 |
| FEI number | 3015491448 |
| Establishment type | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 艾博莱特（苏州）科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 51 Zhousidun road |
| Postal code | 215100 |
| Country | China |
Group
iBrite Suzhou Technology Co., Ltd. is one of 2 plants registered under Pac-Dent Inc..
| Plant | City | Device types |
|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | 26 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Pac-Dent SG | 2018 | 70 |
| Accessories, Retractor, Dental | Class 1 | 2017 | 37 | |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | 2017 | 58 | |
| Collimator, X-Ray | Class 1 | 2017 | 3 | |
| Cup, Prophylaxis | Class 1 | AntiSplatr™ Disposable Prophy Angles | 2017 | 49 |
| Dental Barriers And Sleeves | Class 2 | Pac-Dent Barrier Sleeve, Cover It Barrier Film, Universal Curing Light Shield, Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers, Air Techniques, PSP Barrier Envelopes | 2017 | 12 |
| Handle, Instrument, Dental | Class 1 | 2017 | 29 | |
| Holder, Film, X-Ray | Class 1 | 131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk, 131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk, 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk, 131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk, 131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk and 4 more | 2017 | 40 |
| Instruments, Dental Hand | Class 1 | PJ-01 ProJect™ Composite Dispensing Gun | 2017 | 64 |
| Needle, Dental | Class 1 | 2017 | 56 | |
| Retainer, Matrix | Class 1 | iMatrix Clear | 2017 | 13 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | 2017 | 384 | |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | 2017 | 32 | |
| Syringe, Restorative And Impression Material | Class 1 | 2017 | 49 | |
| Tray, Fluoride, Disposable | Class 1 | Pac-Dent Disposable Tray, Tooth Whitening | 2017 | 22 |
| Tray, Impression, Preformed | Class 1 | 2017 | 73 | |
| Unit, Operative Dental, Accessories | Class 1 | 2017 | 65 | |
| Unit, Syringe, Air And/Or Water | Class 1 | 2017 | 56 |
Clearances
No clearance names iBrite Suzhou Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K151123 | 2016-03-03 | PEM | Traditional | PAC-Dent Inc. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.