Identity
- Trade Name
- Aidite FDA UDI
- Generic Name
- Dental prosthesis dye FDA UDI
- Model / Reference
- Aidite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976029566404 FDA UDI06977585880942 FDA UDI06976029566756 FDA UDI06977585882465 FDA UDI06977585880898 FDA UDI06977585884308 FDA UDI06976029566671 FDA UDI06976087538368 FDA UDI
- 510(k) Number
- K192723 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental prosthesis dye
Aidite by Aidite (Qinhuangdao) Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis dye.
- DD Basic Shade — Dental Direkt GmbH · Class II
- DD Pro Shade Z — Dental Direkt GmbH · Class II
- XTCERA — SHENZHEN XIANGTONG CO., LTD · Class II
- XTCERA — SHENZHEN XIANGTONG CO., LTD · Class II
- Color Liquid — TALLADIUM, INC. · Class II
- XTCERA — DONGGUAN XIANGTONG CO., LTD · Class II
- DD Pro Shade Z — Dental Direkt GmbH · Class II
- XTCERA — SHENZHEN XIANGTONG CO., LTD · Class II
Cleared under the same submission
K192723 also covers:
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology 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 |
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Manufacturer
- Manufacturer
- Aidite (Qinhuangdao) Technology Co., Ltd.
Sources (8)
- FDA UDI 2170f6e6-26f0-4423-8800-2ca38802e6ad 33 fields · synced Jun 7, 2026
- FDA UDI 7417e7a1-2a51-42f1-9498-0f1fb7517d61 33 fields · synced May 26, 2026
- FDA UDI 40915c8e-4bb6-44a7-a080-a93372cb51e3 33 fields · synced May 27, 2026
- FDA UDI 852b664e-7941-4dcf-89a1-a3b03da9faa1 33 fields · synced May 27, 2026
- FDA UDI e70f1fae-bb14-4d01-802a-10980a0e102a 33 fields · synced May 27, 2026
- FDA UDI 1b768adf-f384-4306-821a-b70015234db0 33 fields · synced May 27, 2026
- FDA UDI 4237c0b2-94da-4053-af7a-86e904cfce70 33 fields · synced May 27, 2026
- FDA UDI 5db17e4d-f87d-4aa2-a491-8b19dbcfea7b 33 fields · synced May 27, 2026