Search Results
Found 4 results
510(k) Data Aggregation
K Number
K170261Device Name
Premium Plus Prophy Air Motor
Manufacturer
PREMIUM PLUS INTERNATIONAL LIMITED
Date Cleared
2017-10-19
(265 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PREMIUM PLUS INTERNATIONAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.
Device Description
Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.
Ask a Question
K Number
K163447Device Name
Premium Plus Disposable Barrier Sleeve
Manufacturer
PREMIUM PLUS INTERNATIONAL LIMITED
Date Cleared
2017-06-20
(194 days)
Product Code
PEM
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
PREMIUM PLUS INTERNATIONAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Device Description
Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.
Ask a Question
K Number
K153514Device Name
Premium Plus C01/C02 LED Curing Light
Manufacturer
PREMIUM PLUS INTERNATIONAL LIMITED
Date Cleared
2016-08-22
(259 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
PREMIUM PLUS INTERNATIONAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
Device Description
Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.
Ask a Question
K Number
K100854Device Name
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
Manufacturer
PREMIUM PLUS INTERNATIONAL LIMITED
Date Cleared
2010-12-09
(258 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
PREMIUM PLUS INTERNATIONAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.
Device Description
Not Found
Ask a Question
Page 1 of 1