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Philips Zoom! Chairside Light-Activated Whitening Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Philips Zoom! Chairside Light-Activated Whitening Kit FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Zoom! Tooth Whitening Procedure Kit (25% HP), with NiteWhite 22% CP & Relief ACP Oral Care Gel FDA UDI
- Model / Reference
- DIS556 FDA UDI
- Description
- Zoom! Tooth Whitening Procedure Kit (25% HP), with NiteWhite 22% CP & Relief ACP Oral Care Gel FDA UDI
Identifiers
- Catalog Number
- 881055601540 FDA UDI
- Primary DI / UDI-DI
- 00075020034991 FDA UDI
- 510(k) Number
- K062176 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- 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
Category: Dental coating, tooth-desensitizing, professionalTeeth whitening kit
Philips Zoom! Chairside Light-Activated Whitening Kit by Discus Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Teeth whitening kit.
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- Classic — NU RADIANCE, INC.
- Classic — NU RADIANCE, INC.
- Classic — NU RADIANCE, INC.
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! 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Discus Dental, Inc.
Sources (1)
- FDA UDI 653f9165-33d6-410a-8c85-faa5381775df 35 fields · synced Jun 6, 2026