FDA.report

Absolute Polishers™

Primary DI
10810000526014
Brand
Absolute Polishers™
Company
PARKELL, INC.
Model
S081
Catalog number
S081
Device description
Absolute Polishers™; Cup Shapers (non-diamond)
Published
2019-08-02
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
true

Related Records

Contact Domains

Product Codes

CodeName
EJQWheel, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810000526014PrimaryGS10
00810000526017Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
1081000052601414108100005260141Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
00810000526017140081000052601708100005260170810000526017Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Dental abrasive point, single-useA sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dark, dry-humidity environment
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags

DUNS number
009900424
Device count
24
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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