FDA.report

Paltop

Primary DI
07290114690010
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
80-70004
Catalog number
80-70004
Device description
Closed Tray Impression Coping Screw UNF 1-72 SP
Published
2021-03-02
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
07290114690010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290114690010072901146900107290114690010

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screw analog, single-useA 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. Some types are referred to as a guide pin, and may 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 single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+97246271711zgurgov@keystonedental.com

Regulatory Flags

DUNS number
533836024
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290114695145Paltop55-7206455-720642025-01-13
07290114695152Paltop55-7006055-700602025-01-13
07290114695169Paltop55-7006155-700612025-01-13
07290114695176Paltop55-7006255-700622025-01-13
07290108690040Paltop20-700052024-05-30
07290108690101Paltop20-700112024-05-30
07290108692174Paltop22-700052024-05-30
07290108692235Paltop22-700112024-05-30
07290108695045Paltop20-700222024-05-30
07290108695496Paltop21-700052024-05-30
07290108695557Paltop21-700112024-05-30
07290108695793Paltop20-70005P2024-05-30
07290108695854Paltop20-70011P2024-05-30
07290108696097Paltop20-70022P2024-05-30
07290108696363Paltop21-700222024-05-30
07290108697247Paltop29-700052024-05-30
07290108697308Paltop29-700112024-05-30
07290108697414Paltop29-700222024-05-30
07290108698657Paltop29-70005TC2024-05-30
07290108698718Paltop29-70011TC2024-05-30

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