Identity
- Trade Name
- SOLEIL FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- Disposable Curing Light Sleeves FDA UDI
- Model / Reference
- 123SS FDA UDI
- Description
- Disposable Curing Light Sleeves FDA UDI
Identifiers
- Primary DI / UDI-DI
- D838BC123SS2 FDA UDI
- 510(k) Number
- K163447 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Soleil by Premium Plus International Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163447 also covers:
- SOLEIL — BENCO DENTAL SUPPLY CO.
- Dental Basics — Dental Basics Inc.
- Dental Basics — Dental Basics Inc.
- Dental Basics — Dental Basics Inc.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, 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 |
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Manufacturer
- Manufacturer
- Premium Plus International Limited
Sources (1)
- FDA UDI 6f7ec821-a69e-4d0d-b684-a4c274ce73c6 34 fields · synced May 31, 2026