Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Start kit HYGITECH Reference: HY-0921 The START kit is a great starter kit for light or heavy implantology procedures. Each kit contains 32 separate items: 4 Polyethylene gloves 2 tie-on masks 2 surgical hats 1 Bouffant cap 1 Pair of overshoes 1 Patient gown with cotton cuffs 2 Protective sleeves for tubing (3.5" x 47" / 8 x 120 cm) 1 ice bag 1 surgical drape with adhesive (39" x 39" / 100x100cm) 1 surgical drape with aperture (27.5" x 31.5" / 70 x 80cm) 2 Elastic cap handle covers 1 saliva ejector 1 non-latex elastic band 1 surgical drape with adhesive (59" x 59" / 150x150cm) 1 tube support with adhesive 1 surgical brush with nail cleaner 4 Paper hand-towels 2 surgical gowns with cotton cuffs 1 Wrapping paper FDA UDI
- Model / Reference
- HY-0921 FDA UDI
- Description
- Start kit HYGITECH Reference: HY-0921 The START kit is a great starter kit for light or heavy implantology procedures. Each kit contains 32 separate items: 4 Polyethylene gloves 2 tie-on masks 2 surgical hats 1 Bouffant cap 1 Pair of overshoes 1 Patient gown with cotton cuffs 2 Protective sleeves for tubing (3.5" x 47" / 8 x 120 cm) 1 ice bag 1 surgical drape with adhesive (39" x 39" / 100x100cm) 1 surgical drape with aperture (27.5" x 31.5" / 70 x 80cm) 2 Elastic cap handle covers 1 saliva ejector 1 non-latex elastic band 1 surgical drape with adhesive (59" x 59" / 150x150cm) 1 tube support with adhesive 1 surgical brush with nail cleaner 4 Paper hand-towels 2 surgical gowns with cotton cuffs 1 Wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-0921 FDA UDI
- Primary DI / UDI-DI
- 03615140005135 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
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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 f8224844-e9d7-4acf-94d8-b2165121b077 34 fields · synced May 30, 2026