ProUltra SINE PUSINE6

GUDID D716PUSINE61

ProUltra SINE Tip #6

TULSA DENTAL PRODUCTS LLC

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device IDD716PUSINE61
NIH Device Record Key846ac39a-0506-433b-9325-71ad6fedaba7
Commercial Distribution StatusIn Commercial Distribution
Brand NameProUltra SINE
Version Model NumberPUSINE6
Catalog NumberPUSINE6
Company DUNS942778564
Company NameTULSA DENTAL PRODUCTS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com
Phone+1(800)662-1202
Emailtulsa.orders@dentsply.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD716PUSINE61 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


[D716PUSINE61]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-01-05
Device Publish Date2016-10-07

On-Brand Devices [ProUltra SINE]

D716PUSINE61ProUltra SINE Tip #6
D716PUSINE51ProUltra SINE Tip #5
D716PUSINE41ProUltra SINE Tip #4
D716PUSINE31ProUltra SINE Tip #3
D716PUSINE161ProUltra SINE Tips 1-6

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