FDA.reportPublic FDA data

Vista CT4 (Thin Condensation) Apical Surgery P5 Tip

Primary DI
10818207022346
Brand
Vista CT4 (Thin Condensation) Apical Surgery P5 Tip
Company
Vista Dental
Model
401407
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207022346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702234610818207022346

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818207024968Traxodent Gel AlCl - Bulk Syringe Kit90071012025-06-30
10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30
10818207024982Traxodent Gel AlCl - Value Pack90071022025-06-30
10818207024999Traxodent Gel AlCl - Refill Kit90071032025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe Kit90071062025-06-30
10818207025019Traxodent Gel FS - Value Pack90071072025-06-30
10818207025026Traxodent Gel FS - Refill Kit90071082025-06-30
10818207025033Traxodent Gel Brush Tips90071052025-06-30
10818207025040UniClean90071002025-06-30
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207024913RE-GEN Bioactive EndoPutty Kit5047562024-11-14
10818207024876REGEN Bioactive EndoSealer (SS MST Kit)5047542024-02-02
10818207024838Vista MST Visco Tip SS 17mm 50/cup3124112023-10-02
10818207024845Vista MST Visco Tip SS 22mm 50/cup3124122023-10-02
10818207024852Vista MST Visco Tip SS 17mm 20/cup3124132023-10-02
10818207024869Vista MST Visco Tip SS 22mm 20/cup3124142023-10-02
10818207024333VacuSeal Syringe3713A2023-06-09
10818207024340SmearOFF System (PS System)3730A2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)803803-162023-06-09
10818207024364PS System - Anterior Kit60000022023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800240Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48810120Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000500Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
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