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Hygitech

FDA UDI

Class I (US FDA UDI)

by Hygitech

Identity

Trade Name
HYGITECH FDA UDI
Generic Name
Denture repair kit, professional FDA UDI
Device Name
Protect Extend kit Reference: HY-0991 The HYGITECH Protect Extend kit responds to all needs of implant surgery. We’ve now added to our best seller HYGITECH Protect kit 3 essential elements for implant surgery : -A universal irrigation set -An aspiration set with tube and yankauer cannula -A 2,5mm cannula and adaptor The kit is composed of 49 items: 1 4 Polyethylene gloves 2 2 Tie-on masks 3 1 Surgical hat 4 2 Bouffant caps 5 1 Surgical gown with cotton cuffs 6 1 Assistant gown with cotton cuffs 7 1 Patient gown with cotton cuffs 8 3 Pairs of overshoes 9 2 Sterile brushes with nail cleaner 10 6 Paper hand-towels 11 1 Surgical drape (75x75cm) 1 Instrument table cover (bridge) (90x120cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 Surgical drape with aperture and adhesive (70x100cm) 2 Protective sleeves for tubing (8cmx120cm) 3 Non-latex elastic bands 1 Adhesive film (5cmx80cm) 2 Elastic cap handle covers 2 Adhesive protective covers for control panel 1 Tube support with adhesive 1 Protective PVC X-ray cover 1 universal irrigation set 1 2,5mm cannula with adaptor 1 aspiration set with cannula 1 Wrapping paper FDA UDI
Model / Reference
HY-0991 FDA UDI
Description
Protect Extend kit Reference: HY-0991 The HYGITECH Protect Extend kit responds to all needs of implant surgery. We’ve now added to our best seller HYGITECH Protect kit 3 essential elements for implant surgery : -A universal irrigation set -An aspiration set with tube and yankauer cannula -A 2,5mm cannula and adaptor The kit is composed of 49 items: 1 4 Polyethylene gloves 2 2 Tie-on masks 3 1 Surgical hat 4 2 Bouffant caps 5 1 Surgical gown with cotton cuffs 6 1 Assistant gown with cotton cuffs 7 1 Patient gown with cotton cuffs 8 3 Pairs of overshoes 9 2 Sterile brushes with nail cleaner 10 6 Paper hand-towels 11 1 Surgical drape (75x75cm) 1 Instrument table cover (bridge) (90x120cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 Surgical drape with aperture and adhesive (70x100cm) 2 Protective sleeves for tubing (8cmx120cm) 3 Non-latex elastic bands 1 Adhesive film (5cmx80cm) 2 Elastic cap handle covers 2 Adhesive protective covers for control panel 1 Tube support with adhesive 1 Protective PVC X-ray cover 1 universal irrigation set 1 2,5mm cannula with adaptor 1 aspiration set with cannula 1 Wrapping paper FDA UDI

Identifiers

Catalog Number
HY-0991 FDA UDI
Primary DI / UDI-DI
03615140005173 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hygitech

Sources (1)

  • FDA UDI a9c1321c-b8cf-4d9c-95ad-f98374d85f1d 34 fields · synced May 30, 2026