FDA.reportPublic FDA data

Paltop

Primary DI
07290114693509
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
45-70072
Catalog number
45-70072
Device description
POP Kit Shade A2
Published
2022-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114693509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114693509072901146935097290114693509

GMDN Terms#

Term, Definition table
TermDefinition
Dental shaded pontic kitA collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.

Sterilization Methods#

Method table
Method
High-level Disinfectant

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
Sterilization required before use
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
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.ELM2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.ELM2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.ELM2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.ELM2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.ELM2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.ELM2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.ELM2026-10-09
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25