Power Dental USA 4035-5

GUDID D943403550

POWER FLEX LUXATOR STR 4.5mm ± 5 % TITANIUM

Power Dental U.S.A. Inc.

Dental elevator, tooth/root
Primary Device IDD943403550
NIH Device Record Key1fdb87ff-fc1e-4776-a7be-f52a1d77c332
Commercial Distribution StatusIn Commercial Distribution
Brand NamePower Dental USA
Version Model Number4035-5
Catalog Number4035-5
Company DUNS081305064
Company NamePower Dental U.S.A. Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com
Phone+1(815)363-8003
Emailinfo@powerdentalgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD943403550 [Primary]

FDA Product Code

EMJELEVATOR, SURGICAL, DENTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

[D943403550]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-05
Device Publish Date2021-06-20

On-Brand Devices [Power Dental USA]

D943N812013LATERAL APPROACH REAMER 2.7mm ROUND HANDPIECE USE
D943N8121S00PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II, 8121S SINUS PRO TIP SET OF 8
D943N8120S00SINUS BONE SURGERY TIP SET OF 5 WITH CASSETTE
D943N78307SPECIAL CASSETTE FOR X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHE
D943N7825IMPLANT POSITIONING / DRILL GUIDE KIT
D943N78247TUBES STAND
D943N78246RGF & PRF CASSETTE ONLY
D943N7819DRILL GUIDE & STOPPER SET (8 PCS)
D943N7815POWER IMPLANT REMOVER SINGLE OUT KIT
D943N7806POWER BUR KIT
D943N7640S00PIEZO SCALER TIPS 7640S SATELEC / NSK BASIC SCALING GOLD SET OF 9
D943N7640K16PIEZO SCALER TIPS SATELEC SCALING AND POLISHING KIT GOLD DGD1T,DGD4T,DPD1T,DPD3T,BRUSH,PROPHY 6
D943N7632S00PIEZO SCALER TIPS 7632S EMS REGULAR SCALER CAVITY PREPARATION (6 PCS)
D943N7630K4PIEZO SCALER TIPS EMS Scaler Multi-use Kit Gold DC1T, DG1T, DP1T, DE1T, DSB1T, DP3DT 6 TIPS WITH
D943N7630K2PIEZO SCALER TIPS EMS SCALING AND POLISHING KIT GOLD DG1T, DG4T, DP1T, DP3T, BRUSH, PROPHY 6 TIP
D943N7621PIEZO SCALER SATELEC TIPS, REGULAR AND PERIO, PERIO DEEP. SET OF 8
D943N7620PIEZO SCALER EMS TIPS, REGULAR AND PERIO, PERIO DEEP. SET OF 8
D943N7533CASSETTES UTILITY PARTS BOX 80x30x25Hx0.7t, STAINLESS STEEL, FOR ULTRASONIC
D943N7512P00X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 20 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD.
D943N7512N00X CASSETTES SURGICAL / UTILITY MORE THAN 15 HAND INSTRUMENTS WITH PARTITION ACCESSORY RACK. OR A
D943N7503PB00X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 4 HAND INSTRUMENTS WITH BUR HOLDER(STANDING)
D943N7503P00X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 7 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. 2
D943N7502P00X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 11 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD.
D943N7412R00ENDO BOX BOWL; DIAMETED LENGTH: 2.3IN(5.8CM) DEPTH: 1.2IN(3CM)
D943N7412ENDO BOX; LENGTH:3.9IN (10CM) WIDTH:1.8IN (4.5CM) DEPTH:1.6IN (4.2CM)
D943N7309R00IMPRESSION TRAYS PERFORATED SET UPPER RIGHT/LOWER LEFT 60MM
D943N7309L00IMPRESSION TRAYS PERFORATED SET UPPER LEFT/LOWER RIGHT 60MM
D943N7303SET8IMPRESSION TRAYS SOLID FULL DENTURE SET OF 8, UPPER & LOWER (S, M, L,XL)
D943N7259B00RUBBER DAM CLAMPS. #212 X BLACK . LABIAL CARIES ON ANTERIOR TEETH FLAT JAWS
D943N7250B00RUBBER DAM CLAMPS. #2 X BLACK . PREMOLARS FLAT JAWS
D943N7233B00RUBBER DAM CLAMPS. #0 X BLACK . LONGER PREMOLARS FLAT JAWS, HIGH BOW
D943N7226B00RUBBER DAM CLAMPS. #7 X BLACK . LOWER MOLARS FLAT JAWS
D943N7218B00RUBBER DAM CLAMPS. #8 X BLACK . UPPER MOLARS DEEPLY FESTOONED JAWS
D943N7207B00RUBBER DAM CLAMPS. #14A X BLACK . PARTIALLY ERUPTED, IRREGULARLY SHAPED MOLARS LARGER DEEPLY FES
D943N7206B00RUBBER DAM CLAMPS. #14 X BLACK . PARTIALLY ERUPTED, IRREGULARLY SHAPED MOLARS DEEPLY FESTOONED J
D943N7205B00RUBBER DAM CLAMPS. #1 X BLACK . UPPER PREMOLARS SLIGHLTY FESTOONED JAWS
D943N7200RUBBER DAM CLAMPS KIT (11 PCS)
D943N6969MIRROR WITH HANDLE #4 C/S FRONT SURFACE WITH RULER MIRROR HANDLE THIN OCTAGON (6950-6908A) HANDL
D943N6956MIRROR X POWER MICRO SURGICAL SQUARE 4.5 x 9.5mm (6 PCS/PACK)
D943N6955MIRROR X POWER MICRO SURGICAL ROUND 4mm (6 PCS/PACK)
D943N6954MIRROR LARGE TILTING GLASS C/S FRONT SURFACE 39mm DIAMETER
D943N6953MIRROR DOUBLE SIDE SPECIAL SURGICAL LONG SHAPE C/S FRONT SURFACE 22x37 (6 PCS/PACK)
D943N6950S00MIRROR X POWER SET. ALL FRONT SURFACE MIRROR. SET OF 7
D943N6920E00SCALPEL HANDLE IMPLANT SURGERY SCALPEL HANDLE 13mm Diameter BLACK EDITION
D943N6913MIRROR HANDLE X POWER FOR SURGICAL C/S FOR USE ONLY WITH POWER DUSA MIRRORS.
D943N6750FRAZIER ASPIRATOR SUCTION SET OF 5 FRENCH STYLE WITH CONTROL RELIEF HOLE. 2.0mm, 2.5mm, 3.0mm, 4
D943N6458X FLAP SELF RETRACTOR SET OF 2
D943N6447PREMIUM MOUTH PROPS MIDIUM (CHILD) / LARGE (ADULT) SET OF 2 STEAM GRAVITY STERILIZATION FOR LESS
D943N6440PLASTIC RETRACTOR S/E CLEAN WITH COLD STERILIZATION AND AUTOCLAVE (
D943N6439PLASTIC RETRACTOR D/E CLEAN WITH COLD STERILIZATION AND AUTOCLAVE (

Trademark Results [Power Dental USA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POWER DENTAL USA
POWER DENTAL USA
87852024 not registered Dead/Abandoned
Power Dental U.S.A. Inc.
2018-03-27
© 2024 FDA.report
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