Identity
- Trade Name
- Whitening Handpiece Disposable Shields FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients. FDA UDI
- Model / Reference
- 6400180 FDA UDI
- Description
- Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients. FDA UDI
Identifiers
- Catalog Number
- 6400180 FDA UDI
- Primary DI / UDI-DI
- 00647529002711 FDA UDI
- FDA Product Code
- MMP 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
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
Yes
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
Whitening Handpiece Disposable Shields by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument/equipment drape, single-use, non-sterile.
- Allrap Protective Barriers — METREX RESEARCH · Class I
- Premium Plus — Premium Plus International Limited · Class II
- Delasco Electrosurgical Handpiece Sheath — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- SCHICK ELITE — SIRONA DENTAL, INC. · Class I
- SOLEIL — BENCO DENTAL SUPPLY CO. · Class II
- Pinnacle No-Slip Chair Sleeve — METREX RESEARCH · Class II
- Premium Plus — Premium Plus International Limited · Class II
- Pinnacle Sensor Cover — METREX RESEARCH · Class II
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
- Biolase, Inc.
Sources (1)
- FDA UDI 6047e460-4116-4c10-a52d-876ba2f2a150 35 fields · synced May 30, 2026