FDA.report

Implant Prosthetics

Primary DI
00842092124635
Brand
Implant Prosthetics
Company
PREAT CORPORATION
Model
9002000
Catalog number
9002000
Device description
Astra 3.0mm Analog
Published
2022-06-28
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092180754PackageGS110In Commercial Distribution
00842092180761PackageGS125In Commercial Distribution
00842092124635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092180754008420921807548420921807540842092180754
00842092180761008420921807618420921807610842092180761
00842092124635008420921246358420921246350842092124635

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screw analog, reusableA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 232-7732lauren@preat.com
+1(800) 232-7732info@preat.com
+1 (800) 232-7732info@preat.com

Regulatory Flags

DUNS number
054875224
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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