FDA.report

eZr™

Primary DI
00810038095264
Brand
eZr™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
FPZS01
Catalog number
FPZS01
Device description
Polisher Trial Pack: (1) Coarse Flat End Taper, (1) Medium Large Point, (1) Fine Large Point
Published
2020-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EHLPoint, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810038095264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810038095264008100380952648100380952640810038095264

GMDN Terms

TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization
Sound Waves

Contacts

PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags

DUNS number
057647005
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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