Identity
- Trade Name
- DASH FDA UDI
- Generic Name
- Teeth whitening kit FDA UDI
- Device Name
- DASH Tooth Whitening Procedure Kit FDA UDI
- Model / Reference
- DIS429/01 FDA UDI
- Description
- DASH Tooth Whitening Procedure Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00075020034311 FDA UDI
- 510(k) Number
- K062176 FDA UDI
- FDA Product Code
- OGT FDA UDI
- GMDN Term
- Teeth whitening kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6510 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dash by Discus Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062176 also covers:
- Philips Relief ACP Oral Care Gel — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Relief ACP Oral Care Gel — Discus Dental, Inc.
- Relief ACP — Discus Dental, Inc.
- Relief ACP — Discus Dental, Inc.
- Relief ACP — Discus Dental, Inc.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Discus Dental, Inc.
Sources (1)
- FDA UDI adfca687-df21-416b-97b0-a4807f1f7d00 35 fields · synced May 31, 2026