FDA.report

Osstell SmartPeg Type 93

Primary DI
09010522001035
Brand
Osstell SmartPeg Type 93
Company
Osstell AB
Model
Osstell SmartPeg Type 93
Catalog number
100756
Device description
ISQ Measurement Peg
Published
2022-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09010522001035PackageGS15In Commercial Distribution
09010522001998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09010522001035090105220010359010522001035
09010522001998090105220019989010522001998

GMDN Terms

TermDefinition
Dental implant stability measurement pegA small, sterile, screw-like device intended to be attached to a dental implant or abutment to measure the stability of the implant. It is used with a control unit (not included) which provides an electromagnetic pulsation to create a noninvasive vibrating force in the peg, and the subsequent degree of peg movement provides a measure of dental implant stability. This measurement can be repeated over time to help assess the progress of implant osseointegration. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
633171269
Device count
1
DM exempt
false
Premarket exempt
false
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
false

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