FDA Registration
Active
🇨🇳 China
Shenzhen Sunmc Dental Technology Co., Ltd.
Reg #: 3016998377
·
FEI: 3016998377
·
Expires 2026
Products
17
Proprietary Names
41
Establishment Types
1
Classifications
17
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Registration Details
- Registration Name
- Shenzhen Sunmc Dental Technology Co., Ltd.
- Registration Number
- 3016998377
- FEI Number
- 3016998377
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 313,Building A1,Weicheng Intelligent Industrial Park,No. 533 Gushu First Road,Guxing Community,, Xixiang Subdistrict,Baoan District,
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213026
Owner / Operator
- Firm Name
- Shenzhen Sunmc Dental Technology Co., Ltd.
- Operator Number
- 10070576
- Address
- Room 313, Building A1, Weicheng Intelligent Industrial Park, No. 533 Gushu First Road,, Guxing Community, Xixiang Subdistrict, Bao'an District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
- Correspondent
- Haiwen Wang
US Agent
- Business Name
- JIAMEI CONSULTING INC.
- Contact Name
- Peter Yang
- Address
- 418 Broadway Ste R
- City
- Albany
- State
- NY
- ZIP
- 12207
- Country
- US
- [email protected]
- Phone
- 310 2168437
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2026-03-28 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2020-12-24 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2026-03-28 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2020-12-24 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2026-03-28 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2026-03-28 |
| Alloy, Gold-Based Noble Metal | EJT | Class 2 | Dental | No | 2020-12-24 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2025-11-27 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2020-12-24 |
| Dentures, Full | NSL | Class N | Unknown | No | 2020-12-24 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-09-17 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2022-12-05 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2025-11-25 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2025-05-29 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2020-12-24 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2020-04-17 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2020-12-24 |
Proprietary Names
Orthodontic Wax
Attachment, Precision, All Denture Plastic Model
Co/Cr Partial Framework
Aligner Chewies,Orthodotnic Elastics
Denture, plastic, teeth
Denture Case; Retainer Case; Retainer Box;Denture Box,Invisible Braces Box,Mouth Guard Case
Aligner removal tool,Retainer removal tool
Alloy, gold-based noble metal
Hawley Retainer
Retainer
Alloy, Metal, Base
Dentures, Full
Intraoral Scanner
Clear Aligner
CUSTOMIZED Retainer
DENTAL NIGHT GUARD
Restoration, resin, crown and bridge
Porcelain inlay
Resin baked plastic teeth
Sleeve crown
Porcelain veneer
Metal porcelain teeth
Activity rubber support
Implant: Personalized abutment
CoCr metal porcelain teeth
Invisible denture
Removable partial denture
CoCr metal steel bracket
Pure Ti metal steel bracket
Precision accessories
Semi-precious metal porcelain teeth
All porcelain teeth
Ordinary metal porcelain teeth
Zirconia porcelain teeth
Orthosis
Gold metal porcelain teeth
Full Metal Crown
Dental Crown
PFM Crown
Acrylic Denture
Implant Crown
Establishment Types
Manufacture Medical Device