FDA.report

Power Slot

Primary DI
D798LED11MMP0
Brand
Power Slot
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
LED11MMP
Catalog number
LED11MMP
Device description
11 mm LED Power Slot
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ECPInstrument, Ligature Tucking, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798LED11MMP0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental photo-activated disinfection system handpiece light guideA detachable component of a dental photo-activated disinfection system that is attached to the distal end of the system's handpiece and designed to guide and transmit the photo-activating light from the handpiece into the hard and soft tissue within the oral cavity as part of the bacteria-eliminating process. The device is typically a rigid, curved tube containing a fibreoptic core and is sterilized between patients. It can be used without the attachment of a dedicated tip when larger tissue areas are to be treated. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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