PERFECT TISSUE CONTOURING SYSTEM II
COLTENE/WHALEDENT INC.
COLTENE/WHALEDENT INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2416455 | 2416455 | COLTENE/WHALEDENT INC. | 1 | Y | 2026-01-01 | 235 Ascot Pkwy CUYAHOGA FALLS OH US 44223 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 25256 | 2025573569 | K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER | FRG | 1999-12-16 |
| 25256 | 1938404118 | K993545 | TENAX WHITE POST | ELR | 2000-04-14 |
| 25256 | 1459664220 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | EKX | 1999-03-24 |
| 25256 | 1905519288 | K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | ELC | 1999-01-20 |
| 25256 | 1203044242 | K934192 | PARAPOST XT SYSTEM | ELR | 1994-06-06 |
| 25256 | 2019772823 | K930764 | ENDO-ICE-PULP TESTER-THERMAL | EAT | 1993-05-27 |
| 25256 | 1161679324 | K911225 | TRAY DOUGH | KGS | 1991-04-17 |
| 25256 | 1443176039 | K905640 | SOLID CORE GUTTA PERCHA CARRIER | EKS | 1991-03-05 |
| 25256 | 1327672662 | K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | EMA | 1990-08-28 |
| 25256 | 1011138851 | K900844 | WEDJETS | EIE | 1990-04-16 |
| 25256 | 1908774433 | K900301 | NOVUS BONDING AGENT | EBI | 1990-05-15 |
| 25256 | 2007248909 | K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | KIF | 1990-01-10 |
| 25256 | 1947004089 | K863393 | ENDOCATER | LQY | 1987-06-11 |
| 25256 | 1420757597 | K850863 | ULTRAFIL-LT (GUTTA PERCHA) | EKM | 1985-04-16 |
| 25256 | 1282330235 | K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | EKZ | 1985-05-29 |
| 25256 | 1214246306 | K810026 | DENTAL ENDODONTIC CEMENT | EMA | 1981-01-28 |
| 25256 | 1114622318 | K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | ELC | 2013-08-23 |
| 25256 | 1053263133 | K123582 | ENDO A CLASS | EKX | 2013-08-16 |
| 25256 | 2025309141 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | EBZ | 2012-11-27 |
| 25256 | 1594558854 | K112250 | CHX=CHX PLUS | KJJ | 2011-10-28 |
| 25256 | 1357576908 | K111474 | BINGO PRO | LQY | 2011-11-02 |
| 25256 | 1963563425 | K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | KJJ | 2009-04-03 |
| 25256 | 1489923281 | K071632 | PERFECT TISSUE CONTOURING SYSTEM II | EKZ | 2007-10-18 |
| 25256 | 1137604911 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | ELC | 2006-08-21 |
| 25256 | 1996148973 | K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | KMH | 2005-08-04 |
| 25256 | 1815369885 | K040551 | COLTOLUX LED CURING LIGHT | EBZ | 2004-03-15 |
| 25256 | 1097428589 | K000311 | PARAPOST FIBER WHITE | ELR | 2000-03-14 |
| 25256 | 1049426762 | ||||
| 25256 | 1147041063 | ||||
| 25256 | 1191770003 | ||||
| 25256 | 1297911793 | ||||
| 25256 | 1387686263 | ||||
| 25256 | 1438440763 | ||||
| 25256 | 1536247987 | ||||
| 25256 | 1594065958 | ||||
| 25256 | 1619954921 | ||||
| 25256 | 1670024892 | ||||
| 25256 | 1711607885 | ||||
| 25256 | 1750694886 | ||||
| 25256 | 1976594925 | ||||
| 25256 | 1000715653 | ||||
| 25256 | 1020208865 | ||||
| 25256 | 1021745698 | ||||
| 25256 | 1036253574 | ||||
| 25256 | 1048897083 | ||||
| 25256 | 1084830817 | ||||
| 25256 | 1105312235 | ||||
| 25256 | 1106971740 | ||||
| 25256 | 1170696087 | ||||
| 25256 | 1213413554 | ||||
| 25256 | 1411375131 | ||||
| 25256 | 1416389496 | ||||
| 25256 | 1423554704 | ||||
| 25256 | 1440667840 | ||||
| 25256 | 1579012852 | ||||
| 25256 | 1625530902 | ||||
| 25256 | 1627131592 | ||||
| 25256 | 1651744443 | ||||
| 25256 | 1761942105 | ||||
| 25256 | 1768911352 | ||||
| 25256 | 1818105302 | ||||
| 25256 | 1856480812 | ||||
| 25256 | 1880185705 | ||||
| 25256 | 1944757892 | ||||
| 25256 | 1952225384 | ||||
| 25256 | 1971744727 | ||||
| 25256 | 1973173508 | ||||
| 25256 | 1983387235 | ||||
| 25256 | 1985261892 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ELC | 3 | 2013-08-23 |
| ELR | 3 | 2000-04-14 |
| EKX | 2 | 2013-08-16 |
| EBZ | 2 | 2012-11-27 |
| LQY | 2 | 2011-11-02 |
| KJJ | 2 | 2011-10-28 |
| EKZ | 2 | 2007-10-18 |
| EMA | 2 | 1990-08-28 |
| KMH | 1 | 2005-08-04 |
| FRG | 1 | 1999-12-16 |
| EAT | 1 | 1993-05-27 |
| KGS | 1 | 1991-04-17 |
| EKS | 1 | 1991-03-05 |
| EBI | 1 | 1990-05-15 |
| EIE | 1 | 1990-04-16 |
| KIF | 1 | 1990-01-10 |
| EKM | 1 | 1985-04-16 |
PMN#
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
COLTENE/WHALEDENT INC.
COLTOLUX LED CURING LIGHT
COLTENE/WHALEDENT INC.
ONE COAT SE BOND
COLTENE/WHALEDENT INC.
COLTOSOL F
COLTENE/WHALEDENT INC.
SYNERGY FLOW
COLTENE/WHALEDENT INC.
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
COLTENE/WHALEDENT INC.
TENAX WHITE POST
COLTENE/WHALEDENT INC.
PARAPOST FIBER WHITE
COLTENE/WHALEDENT INC.
MODIFICATION OF PARAPOST CEMENT
COLTENE/WHALEDENT INC.
PARAPOST SYSTEM STERILIZABLE ORGANIZER
COLTENE/WHALEDENT INC.
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
COLTENE/WHALEDENT INC.
BIOSONIC ULTRASONIC SCALER SYSTEM
COLTENE/WHALEDENT INC.
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
COLTENE/WHALEDENT INC.
SYNERGY
COLTENE/WHALEDENT INC.
COLTOLUX LIGHT METER
COLTENE/WHALEDENT INC.
COLTOLUX 3, COLTOLUX 4
COLTENE/WHALEDENT INC.
PARAPOST CEMENT
COLTENE/WHALEDENT INC.
PARAPOST XT SYSTEM
COLTENE/WHALEDENT INC.
COLTENE A.R.T. BOND
COLTENE/WHALEDENT INC.
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
COLTENE/WHALEDENT INC.