FDA.report

Paltop

Primary DI
07290108696332
Brand
Paltop
Company
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Model
60-70092
Catalog number
60-70092
Device description
Osteotome for DIVA Ø3.2/3.75mm
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
07290108696332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290108696332072901086963327290108696332

GMDN Terms

TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. 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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