Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Ultraviolet view box FDA UDI
- Device Name
- Protective glasses for both the dentist and the patient, ideal during polymerisation of dental pulp. • Perfect protection: protects against splashes, UV rays (efficient against the UVC) and blue light, improves contrast and reduces eye fatigue • Full lateral protection • Single-piece frame for the best eye protection • Can be worn alone or over glasses. • Anti-fog and anti-scratch treatment on the inside and front of glasses • Provides comfort during procedures : doesn’t affect vision during a procedure • Dimensions: 19cm width x 7cm height • Light weight: 36 g FDA UDI
- Model / Reference
- HY-07015 FDA UDI
- Description
- Protective glasses for both the dentist and the patient, ideal during polymerisation of dental pulp. • Perfect protection: protects against splashes, UV rays (efficient against the UVC) and blue light, improves contrast and reduces eye fatigue • Full lateral protection • Single-piece frame for the best eye protection • Can be worn alone or over glasses. • Anti-fog and anti-scratch treatment on the inside and front of glasses • Provides comfort during procedures : doesn’t affect vision during a procedure • Dimensions: 19cm width x 7cm height • Light weight: 36 g FDA UDI
Identifiers
- Catalog Number
- HY-07015 FDA UDI
- Primary DI / UDI-DI
- 03615140000383 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Ultraviolet view box FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet view box
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet view box.
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
- Hygitech
Sources (1)
- FDA UDI 99797730-8bde-4207-a0a7-e32914914924 34 fields · synced May 30, 2026