FDA.reportPublic FDA data

Paltop

Primary DI
07290108695021
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
30-70502
Catalog number
30-70502
Device description
Digital Analog NP
Published
2021-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108695021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108695021072901086950217290108695021

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246271711zgurgov@keystonedental.com

Regulatory Flags#

DUNS number
533836024
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053262N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053279N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053286N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01