Search Results
Found 2 results
510(k) Data Aggregation
K Number
K132953Device Name
TIDISHEILD
Manufacturer
TIDI PRODUCTS, LLC
Date Cleared
2014-02-18
(151 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
TIDI PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves are non-sterile and are intended for single patient use only.
Device Description
Not Found
Ask a Question
K Number
K100800Device Name
TIDI FACEMASK
Manufacturer
TIDI PRODUCTS, LLC
Date Cleared
2010-06-14
(84 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
TIDI PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Device Description
The TIDI® Facemask are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of 100% SBPP. The nosepieces are made of aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The face mask covers the nose and mouth, and is secured to the face using ear loops.
Ask a Question
Page 1 of 1