Primary Device ID | D9435601L5601XL0 |
NIH Device Record Key | 5d19b41c-6aca-4664-a484-db1b5d3ac112 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Power Dental U.S.A., Inc. |
Version Model Number | 5601L/5601XL |
Catalog Number | 5601L/5601XL |
Company DUNS | 081305064 |
Company Name | Power Dental U.S.A. Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com | |
Phone | +1(815)363-8003 |
info@powerdentalgroup.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D9435601L5601XL0 [Primary] |
HXZ | CUTTER, WIRE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
[D9435601L5601XL0]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-12-11 |
Device Publish Date | 2021-07-17 |
D943NMM1005 | EXP 23 S/E, 1EZ, ENGRAVE 20-EXP 23 |
D943N88612 | DUSA #5756, Large Disc(22mm) Guard w/Adapter |
D943N88611 | DUSA #5755, Small Disc(19mm) Guard with Adapter |
D943N8001 | POWER FULL EQUIPMENT PERFECT SETTING (1 SUITCASE) |
D943N7953 | BASIC SURGICAL FULL KIT 27 INSTRUMENTS PREMIUM QUALITY |
D943N7830 | X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHET DRIVER, SET OF 7 |
D943N7828 | EASY IMPLANT Lateral Sinus Lifting Special Water Separating / 2mm Stop Drill System with Cassett |
D943N7827 | SURGICAL DRILL POINT PILOT 1.1 x 17mm ( 3 - 6 - 9 -12mm ) |
D943N7826 | C& L SINUS COMPLETE KIT |
D943N7822 | SCREW & FIXTURE REMOVER KIT |
D943N7821 | POWER ROOT EXTRACTION HANDPIECE ANCHOR 30mm |
D943N7820 | X POWER EXTRACTOR BASIC SET |
D943N7814 | POWER EASY BONE EXPANDER KIT |
D943N7813 | POWER PROSTHETIC KIT ..1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen...1.25mm: Astra, D |
D943N7812 | "POWER DRILL STOP SYSTEM..This kit is composed of 5 kinds of Drills of 2mm, 2.5mm, 3.3mm , diam |
D943N7811 | POWER WATER RISING SYSTEM |
D943N7810 | POWER BONE COLLECTOR NEVER LOSS |
D943N7809 | POWER BONE EXPAND / SPREADING KIT |
D943N7808 | POWER BONE SPREADING KIT |
D943N7805 | 8120-11 BONE SPREADER 3.0mm LOW SPEED HANDPIECE USE |
D943N7804 | 8120-10 BONE SPREADER 2.5mm LOW SPEED HANDPIECE USE |
D943N7803 | POWER LATERAL APPROACH KIT |
D943N7802 | POWER CRESTAL APPROACH KIT |
D943N7801 | POWER AQUA SINUS LIFT KIT |
D943N7735 | TITANIUM, MICRO SURGICAL GERALD STR 15.5cm NON SERRATED |
D943N7734 | TITANIUM, MICRO SURGICAL GERALD KOCHER CVD NON SERRATED TEETH |
D943N7733 | TITANIUM, MICRO SURGICAL GERALD CVD (7.1in=18cm) SERRATED |
D943N7732 | TITANIUM, MICRO SURGICAL GERALD STR (7.1in=18cm) SERRATED |
D943N7731 | TITANIUM, MICRO SURGICAL GERALD CVD (7.1in=18cm) NON SERRATED |
D943N7730 | TITANIUM, MICRO SURGICAL GERALD STR (7.1in=18cm) NON SERRATED |
D943N7723 | TITANIUM, MICRO SURGICAL CASTOVIEJO CVD (6.3in=16cm) SERRATED |
D943N7722 | TITANIUM, MICRO SURGICAL CASTOVIEJO STR (6.3in=16cm) SERRATED |
D943N7721 | TITANIUM, MICRO SURGICAL CASTOVIEJO CVD (6.3in=16cm) NON SERRATED |
D943N7720 | TITANIUM, MICRO SURGICAL CASTOVIEJO STR (6.3in=16cm) NON SERRATED |
D943N7710 | TITANIUM, MICRO SURGICAL CASTRO SCISSOR CVD (5.5in=14cm) NON SERRATED |
D943N7701 | TITANIUM, MICRO SURGICAL TISSUE FORCEP CVD 110mm NON SERRATED |
D943N7700 | TITANIUM, MICRO SURGICAL TISSUE FORCEP STR 110mm NON SERRATED |
D943N7643 | HANDPIECE POLISHING TIPS 6 TIPS WITH CASSETTE |
D943N7640K18 | PIEZO SCALER TIPS SATELEC DC1T,DGD1T,DPD1T,DED1T,DSBD1T,DPD3DT 6TIP WITH CASSETTE |
D943N7640 | PIEZO SCALER Model:7640 SATELEC NO LED Automatic water supply Function: Scaling ,Perio,Endodonti |
D943N7615 | CAVITRON ENDO 18AG/25K ULTRASONIC UNIT , ENDODONTIC INSERT UNIT POWER SETTING: LOW-MED |
D943N7614 | CAVITRON ULTRA SONIC SCALER SPA 10/30K WITH SILICONE SLEEVES |
D943N7613 | CAVITRON ULTRA SONIC SCALER SPA 10/25K WITH SILICONE SLEEVES |
D943N7611 | ULTRASONIC INSERT CAVITRON 30KHZDF100/30K PERIO THIN UNIT POWER SETTING : LOW-MED INTERNAL WATER |
D943N7610 | ULTRASONIC INSERT CAVITRON 30KHZ DF10/30K UNIVERSAL INTERNAL WATER FLOW |
D943N7609 | BEVERTAIL CAVITRON DF3/30K UNIT POWER SETTING : LOW-MED |
D943N7607 | ULTRASONIC INSERT CAVITRON 25KHZ DF100/25K PERIO THIN UNIT POWER SETTING : LOW-MED INTERNAL WATE |
D943N7606 | ULTRASONIC INSERT CAVITRON 25KHZ DF10/25K UNIVERSAL INTERNAL WATER FLOW |
D943N7605 | BEAVERTAIL CAVITRON DF3/25K |
D943N7604 | ULTRASONIC INSERT CAVITRON 30KHZ PERIO THIN UNIT POWER SETTING : LOW-MED EXTERNAL WATER FLOW |