| Primary Device ID | D943N7815 | 
| NIH Device Record Key | 9d3672ee-a93d-4a20-bcc0-77c4876fd0d7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Power Dental USA | 
| Version Model Number | N7815 | 
| Catalog Number | N7815 | 
| 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 | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | |
| Phone | +1(815)363-8003 | 
| info@mydentalusa.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D943N7815 [Primary] | 
| FTY | TAPE, MEASURING, RULERS AND CALIPERS | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
[D943N7815]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-01-17 | 
| Device Publish Date | 2022-01-08 | 
| D943N812013 | LATERAL APPROACH REAMER 2.7mm ROUND HANDPIECE USE | 
| D943N8121S00 | PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II, 8121S SINUS PRO TIP SET OF 8 | 
| D943N8120S00 | SINUS BONE SURGERY TIP SET OF 5 WITH CASSETTE | 
| D943N78307 | SPECIAL CASSETTE FOR X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHE | 
| D943N7825 | IMPLANT POSITIONING / DRILL GUIDE KIT | 
| D943N78247 | TUBES STAND | 
| D943N78246 | RGF & PRF CASSETTE ONLY | 
| D943N7819 | DRILL GUIDE & STOPPER SET (8 PCS) | 
| D943N7815 | POWER IMPLANT REMOVER SINGLE OUT KIT | 
| D943N7806 | POWER BUR KIT | 
| D943N7640S00 | PIEZO SCALER TIPS 7640S SATELEC / NSK BASIC SCALING GOLD SET OF 9 | 
| D943N7640K16 | PIEZO SCALER TIPS SATELEC SCALING AND POLISHING KIT GOLD DGD1T,DGD4T,DPD1T,DPD3T,BRUSH,PROPHY 6 | 
| D943N7632S00 | PIEZO SCALER TIPS 7632S EMS REGULAR SCALER CAVITY PREPARATION (6 PCS) | 
| D943N7630K4 | PIEZO SCALER TIPS EMS Scaler Multi-use Kit Gold DC1T, DG1T, DP1T, DE1T, DSB1T, DP3DT 6 TIPS WITH | 
| D943N7630K2 | PIEZO SCALER TIPS EMS SCALING AND POLISHING KIT GOLD DG1T, DG4T, DP1T, DP3T, BRUSH, PROPHY 6 TIP | 
| D943N7621 | PIEZO SCALER SATELEC TIPS, REGULAR AND PERIO, PERIO DEEP. SET OF 8 | 
| D943N7620 | PIEZO SCALER EMS TIPS, REGULAR AND PERIO, PERIO DEEP. SET OF 8 | 
| D943N7533 | CASSETTES UTILITY PARTS BOX 80x30x25Hx0.7t, STAINLESS STEEL, FOR ULTRASONIC | 
| D943N7512P00 | X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 20 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. | 
| D943N7512N00 | X CASSETTES SURGICAL / UTILITY MORE THAN 15 HAND INSTRUMENTS WITH PARTITION ACCESSORY RACK. OR A | 
| D943N7503PB00 | X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 4 HAND INSTRUMENTS WITH BUR HOLDER(STANDING) | 
| D943N7503P00 | X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 7 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. 2 | 
| D943N7502P00 | X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 11 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. | 
| D943N7412R00 | ENDO BOX BOWL; DIAMETED LENGTH: 2.3IN(5.8CM) DEPTH: 1.2IN(3CM) | 
| D943N7412 | ENDO BOX; LENGTH:3.9IN (10CM) WIDTH:1.8IN (4.5CM) DEPTH:1.6IN (4.2CM) | 
| D943N7309R00 | IMPRESSION TRAYS PERFORATED SET UPPER RIGHT/LOWER LEFT 60MM | 
| D943N7309L00 | IMPRESSION TRAYS PERFORATED SET UPPER LEFT/LOWER RIGHT 60MM | 
| D943N7303SET8 | IMPRESSION TRAYS SOLID FULL DENTURE SET OF 8, UPPER & LOWER (S, M, L,XL) | 
| D943N7259B00 | RUBBER DAM CLAMPS. #212 X BLACK . LABIAL CARIES ON ANTERIOR TEETH FLAT JAWS | 
| D943N7250B00 | RUBBER DAM CLAMPS. #2 X BLACK . PREMOLARS FLAT JAWS | 
| D943N7233B00 | RUBBER DAM CLAMPS. #0 X BLACK . LONGER PREMOLARS FLAT JAWS, HIGH BOW | 
| D943N7226B00 | RUBBER DAM CLAMPS. #7 X BLACK . LOWER MOLARS FLAT JAWS | 
| D943N7218B00 | RUBBER DAM CLAMPS. #8 X BLACK . UPPER MOLARS DEEPLY FESTOONED JAWS | 
| D943N7207B00 | RUBBER DAM CLAMPS. #14A X BLACK . PARTIALLY ERUPTED, IRREGULARLY SHAPED MOLARS LARGER DEEPLY FES | 
| D943N7206B00 | RUBBER DAM CLAMPS. #14 X BLACK . PARTIALLY ERUPTED, IRREGULARLY SHAPED MOLARS DEEPLY FESTOONED J | 
| D943N7205B00 | RUBBER DAM CLAMPS. #1 X BLACK . UPPER PREMOLARS SLIGHLTY FESTOONED JAWS | 
| D943N7200 | RUBBER DAM CLAMPS KIT (11 PCS) | 
| D943N6969 | MIRROR WITH HANDLE #4 C/S FRONT SURFACE WITH RULER MIRROR HANDLE THIN OCTAGON (6950-6908A) HANDL | 
| D943N6956 | MIRROR X POWER MICRO SURGICAL SQUARE 4.5 x 9.5mm (6 PCS/PACK) | 
| D943N6955 | MIRROR X POWER MICRO SURGICAL ROUND 4mm (6 PCS/PACK) | 
| D943N6954 | MIRROR LARGE TILTING GLASS C/S FRONT SURFACE 39mm DIAMETER | 
| D943N6953 | MIRROR DOUBLE SIDE SPECIAL SURGICAL LONG SHAPE C/S FRONT SURFACE 22x37 (6 PCS/PACK) | 
| D943N6950S00 | MIRROR X POWER SET. ALL FRONT SURFACE MIRROR. SET OF 7 | 
| D943N6920E00 | SCALPEL HANDLE IMPLANT SURGERY SCALPEL HANDLE 13mm Diameter BLACK EDITION | 
| D943N6913 | MIRROR HANDLE X POWER FOR SURGICAL C/S FOR USE ONLY WITH POWER DUSA MIRRORS. | 
| D943N6750 | FRAZIER ASPIRATOR SUCTION SET OF 5 FRENCH STYLE WITH CONTROL RELIEF HOLE. 2.0mm, 2.5mm, 3.0mm, 4 | 
| D943N6458 | X FLAP SELF RETRACTOR SET OF 2 | 
| D943N6447 | PREMIUM MOUTH PROPS MIDIUM (CHILD) / LARGE (ADULT) SET OF 2 STEAM GRAVITY STERILIZATION FOR LESS | 
| D943N6440 | PLASTIC RETRACTOR S/E CLEAN WITH COLD STERILIZATION AND AUTOCLAVE ( | 
| D943N6439 | PLASTIC RETRACTOR D/E CLEAN WITH COLD STERILIZATION AND AUTOCLAVE ( | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  POWER DENTAL USA  87852024  not registered Dead/Abandoned | Power Dental U.S.A. Inc. 2018-03-27 |