Identity
- Trade Name
- XTCERA FDA UDI
- Generic Name
- Dental prosthesis dye FDA UDI
- Model / Reference
- 5M1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942377252948 FDA UDI
- 510(k) Number
- K220017 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental prosthesis dye FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental prosthesis dye
Xtcera by Shenzhen Xiangtong Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis dye.
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- DD Pro Shade Z — Dental Direkt GmbH · Class II
- Color Liquid — TALLADIUM, INC. · Class II
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd. · Class II
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd. · Class II
Cleared under the same submission
K220017 also covers:
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
- XTCERA — DONGGUAN XIANGTONG CO., LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Xiangtong Co., Ltd
Sources (1)
- FDA UDI 21d29cfa-7d5a-42f4-a6f6-7c319fb9481e 33 fields · synced May 30, 2026