FDA.report

Sherlock

Primary DI
D86336640
Brand
Sherlock
Company
OPEN IMPLANTS, LLC
Model
3664
Catalog number
3664
Device description
Sherlock Scan Post, Astra Tech OsseoSpeed 3.5/4.0
Published
2017-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D86336640PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080362928
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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D86349340Sherlock49342021-02-18
D86349350Sherlock49352021-02-18
D86349380Sherlock49382021-02-18
D86349390Sherlock493949392021-02-18

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