Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Paro kit HYGITECH Reference: HY-08811 The PARO kit is specifically designed for preventing cross-infection during your short routine procedures: tooth extraction, parodontology. The kit contains 12 items. 1 Surgical hat 1 Bouffant cap 1 Tie-on mask 1 Pair of overshoes 1 Surgical brush with nail cleaner 2 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Surgical drape with aperture and adhesive (29.5"x 35.5"/ 75x90cm) 1 U-Shaped surgical drape with adhesive (29.5"x 35.5"/ 75x90cm) 1 Wrapping paper FDA UDI
- Model / Reference
- HY-08811 FDA UDI
- Description
- Paro kit HYGITECH Reference: HY-08811 The PARO kit is specifically designed for preventing cross-infection during your short routine procedures: tooth extraction, parodontology. The kit contains 12 items. 1 Surgical hat 1 Bouffant cap 1 Tie-on mask 1 Pair of overshoes 1 Surgical brush with nail cleaner 2 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Surgical drape with aperture and adhesive (29.5"x 35.5"/ 75x90cm) 1 U-Shaped surgical drape with adhesive (29.5"x 35.5"/ 75x90cm) 1 Wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-08811 FDA UDI
- Primary DI / UDI-DI
- 03615140005272 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Denture repair kit, professional FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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: Denture repair kit, professional
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture repair kit, professional.
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
- Beesure — ASCEND EAGLE INCORPORATED · Class I
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
- Bosworth Duz-All — Harry J. Bosworth Co. · Class II
- Mizzy Millennium — Keystone Industries · Class II
- Bosworth TruRepair — Harry J. Bosworth Co. · Class II
- Bosworth Duz-All — Harry J. Bosworth Co. · Class II
- Mizzy Millennium — Keystone Industries · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI ae71f157-6468-4c33-a1df-ca27664ea35a 34 fields · synced May 30, 2026