FDA.report

Paltop

Primary DI
07290108699784
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
30-70309
Catalog number
30-70309
Device description
Fully Guided Drill Ø4.2mm L20mm
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
false

Related Records

Contact Domains

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290108699784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290108699784072901086997847290108699784

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable 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
true
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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