| Primary Device ID | D94335410 | 
| NIH Device Record Key | 6b0b9291-9293-42a0-ac01-92b719bec88b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Power Dental U.S.A., Inc. | 
| Version Model Number | 3541 | 
| Catalog Number | 3541 | 
| 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 | true | 
| 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 | |
| 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 | D94335410 [Primary] | 
| DZN | Instruments, Dental Hand | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
[D94335410]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2024-12-05 | 
| Device Publish Date | 2021-06-20 | 
| 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 |