FDA.reportPublic FDA data

Paltop

Primary DI
07290108693249
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
56-72045
Catalog number
56-72045
Device description
Conical Open Tray Impression coping Dia 4.5mm
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130462000PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANTPaltop Advanced Dental Solutions, Ltd.2013-08-27DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108693249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108693249072901086932497290108693249

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246271711info@paltopdental.com

Regulatory Flags#

DUNS number
533836024
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290108695922Paltop20-70018P20-70018P2021-03-02
07290108695939Paltop20-70019P20-70019P2021-03-02
07290108695946Paltop20-70020P20-70020P2021-03-02
07290108695953Paltop20-70021P20-70021P2021-03-02
07290114695145Paltop55-7206455-720642025-01-13
07290114695152Paltop55-7006055-700602025-01-13
07290114695169Paltop55-7006155-700612025-01-13
07290114695176Paltop55-7006255-700622025-01-13
07290114692168Paltop55-700462023-07-17
07290114692175Paltop55-700472023-07-17
07290114692182Paltop55-700482023-07-17
07290114692199Paltop55-700492023-07-17
07290114692205Paltop55-700502023-07-17
07290114693738Paltop40-703302023-07-17
07290114693745Paltop40-703312023-07-17
07290114693752Paltop40-703322023-07-17
07290114693769Paltop24-70001MC24-70001MC2023-02-09
07290114693776Paltop24-70002MC24-70002MC2023-02-09
07290114693783Paltop24-70003MC24-70003MC2023-02-09
07290114693790Paltop24-70004MC24-70004MC2023-02-09

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