FDA.report

Vista SPRD (Right Angle Diamond) Apical Surgery P5 Tip

Primary DI
10818207022285
Brand
Vista SPRD (Right Angle Diamond) Apical Surgery P5 Tip
Company
Vista Dental
Model
401305
Published
2022-09-01
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
EMKCurette, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818207022285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081820702228510818207022285

GMDN Terms

TermDefinition
Dental ultrasonic surgical system handpiece tipA removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
2626369755info@vista-dental.com

Regulatory Flags

DUNS number
036623932
Device count
1
DM exempt
false
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

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