Plak Smacker
Stannous Fluoride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2024980 | 3008875470 | YOUNG INNOVATIONS INC. | 1 | Y | 2026-01-01 | 2260 Wendt St Algonquin IL US 60102 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00840326423868 | Astek - Pro-Matrix Curve 4.5mm Narrow Band | +1 (800) 558-6684 | support@youngspecialties.com |
| 00840326423875 | Astek - Pro-Matrix 6mm Wide Band | +1 (800) 558-6684 | support@youngspecialties.com |
| 00840326423882 | Astek - Pro-Matrix Curve 6mm Wide Band | +1 (800) 558-6684 | support@youngspecialties.com |
| 00840326426630 | Astek - Pro-Matrix Sample Pack | +1 (800) 558-6684 | support@youngspecialties.com |
| 00843471150061 | Astek - Pro-Matrix Narrow | +1 (800) 558-6684 | support@youngspecialties.com |
| 00843471150078 | Astek - Pro-Matrix Wide | +1 (800) 558-6684 | support@youngspecialties.com |
| 00843471150085 | Astek - Pro-Matrix Curve Narrow | +1 (800) 558-6684 | support@youngspecialties.com |
| 00843471150092 | Astek - Pro-Matrix Curve Wide | +1 (800) 558-6684 | support@youngspecialties.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 98062 | 1766556449 | K993811 | MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE | LYY | 2000-03-02 |
| 98062 | 1383130085 | K992001 | TRAY-LINK | ELW | 1999-11-02 |
| 98062 | 1438033305 | K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1998-10-15 |
| 98062 | 1262819153 | K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | 1998-11-05 |
| 98062 | 1684509531 | K974894 | KROMATICA COLOR CHANGING ALGINATE | ELW | 1998-02-12 |
| 98062 | 1038724048 | K973059 | PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) | LZA | 1997-11-07 |
| 98062 | 1275070345 | K971130 | DEFEND FLUID RESISTANT PLEATED MASK | FXX | 1997-06-27 |
| 98062 | 1117865147 | K961754 | SAFETY RELEASE MODULE | DZB | 1996-07-10 |
| 98062 | 1664161672 | K953504 | MICROPRIME | KLE | 1995-10-03 |
| 98062 | 1613303914 | K940120 | ALPHA-DENT | ELW | 1994-02-25 |
| 98062 | 1157245094 | K936095 | GAUZE SPONGE | EFQ | 1994-02-02 |
| 98062 | 1621316734 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | 1994-01-07 |
| 98062 | 1605481363 | K914322 | BARITONE C2 & BARITONE L3 | EBC | 1991-10-23 |
| 98062 | 1965410396 | K902075 | INTRIGUE CERAMIC BRACKET | NJM | 1990-08-06 |
| 98062 | 1493833363 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | 1989-11-03 |
| 98062 | 1705527426 | K882436 | LASER - 1000 | EHD | 1988-08-04 |
| 98062 | 1318176418 | K871558 | DENTAL FACE MASKS, POLYESTER | FXX | 1987-07-22 |
| 98062 | 1127199993 | K870236 | PANORAMIC X-RAY MODEL PC-1000 | EHD | 1987-02-13 |
| 98062 | 1014842243 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | ELW | 1980-07-08 |
| 98062 | 1411043163 | K251196 | Composite Orthodontic Brackets and Buttons | DYW | 2025-04-21 |
| 98062 | 1373351562 | K233918 | Dental Barrier and Sleeves | PEM | 2024-05-09 |
| 98062 | 1416078701 | K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | 2022-11-20 |
| 98062 | 1558614146 | K202903 | Surgical Face Mask | FXX | 2022-03-24 |
| 98062 | 1247717580 | K201785 | EPIEN Dental Cleanser | KJJ | 2021-09-09 |
| 98062 | 1897076035 | K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | LZA | 2018-05-10 |
| 98062 | 1922613460 | K171823 | U&U Indicator tape and strip | JOJ | 2018-02-22 |
| 98062 | 1117101471 | K162258 | Self Sealing Sterilization Pouches | FRG | 2017-04-28 |
| 98062 | 1968642687 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | OAS | 2016-02-04 |
| 98062 | 1671315586 | K143637 | U&U Sterilization Pouch and Roll | FRG | 2015-09-09 |
| 98062 | 1276288283 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | LZA | 2015-01-22 |
| 98062 | 1409887357 | K141130 | ENCOMPASS | MUH | 2014-07-30 |
| 98062 | 1653015282 | K132953 | TIDISHEILD | PEM | 2014-02-18 |
| 98062 | 1428083039 | K121915 | BRIGHT RESTORATIVE MATERIALS | EBF | 2012-09-28 |
| 98062 | 1564324030 | K112693 | NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES | LYY | 2012-09-12 |
| 98062 | 1414012366 | K110371 | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY | MUH | 2011-03-17 |
| 98062 | 1740894574 | K102836 | BONASIL A+ IMPRESSION MATERIALS | ELW | 2011-01-13 |
| 98062 | 1024838408 | K102753 | TURBO TEMP 3 | EBG | 2011-02-04 |
| 98062 | 1185283913 | K102561 | ORTHODONTIC CERAMIC BRACKET | NJM | 2011-01-25 |
| 98062 | 2034354383 | K102257 | NANOCERAM- BRIGHT | EBF | 2010-11-19 |
| 98062 | 1806887390 | K102254 | DMP SINGLE BONDING | KLE | 2010-11-23 |
| 98062 | 1972252095 | K102252 | DMP PIT & FISSURE SEALANT | EBC | 2010-12-03 |
| 98062 | 1607073743 | K072614 | MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE | LYY | 2008-04-15 |
| 98062 | 1614808759 | K072406 | NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) | LYY | 2008-03-21 |
| 98062 | 1688650147 | K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | EFB | 2007-10-12 |
| 98062 | 1280925312 | K060347 | B&L L-BETA, MODEL WL-B1 | EKR | 2006-06-05 |
| 98062 | 1962094968 | K051664 | SCAN300FP / RETROPAN (VDC) | MUH | 2005-07-20 |
| 98062 | 1048785405 | K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | EHD | 2005-01-13 |
| 98062 | 1648958510 | K042879 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING | LZA | 2005-01-13 |
| 98062 | 1331893689 | K042828 | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | EKR | 2004-12-01 |
| 98062 | 2032989723 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | 2004-05-14 |
| 98062 | 1654165626 | K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | FRC | 2004-05-25 |
| 98062 | 1629610668 | K032190 | DISPOSABLE POWDERED VINYL EXAM GLOVES | LYZ | 2003-08-14 |
| 98062 | 1891970676 | K032172 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | LYZ | 2003-08-14 |
| 98062 | 1392034695 | K021220 | NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2002-06-06 |
| 98062 | 1780055082 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | 2002-07-23 |
| 98062 | 1057849392 | K014249 | JETPOLISHER | KOJ | 2002-02-19 |
| 98062 | 1614351109 | K013969 | MINIBLASTER | KOJ | 2002-01-10 |
| 98062 | 1200046843 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | 2001-10-24 |
| 98062 | 1585707569 | K011377 | NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 | LYY | 2001-06-07 |
| 98062 | 1673233006 | K011370 | NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG | LYY | 2001-06-07 |
| 98062 | 1356117094 | K011179 | DELDENT ULTRASONIC INSERTS | ELC | 2001-06-05 |
| 98062 | 1898065199 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | 2001-02-09 |
| 98062 | 1213700372 | K002521 | SPARTAN MTS | ELC | 2000-11-13 |
| 98062 | 1140310694 | K001619 | MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE) | LZA | 2000-07-26 |
| 98062 | 1589158749 | K000999 | MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2000-05-22 |
| 98062 | 1383530792 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB | 2000-06-09 |
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| 98062 | 1728151155 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZA | 9 | 2022-11-20 |
| LYY | 9 | 2012-09-12 |
| ELW | 7 | 2011-01-13 |
| FXX | 4 | 2022-03-24 |
| FRG | 3 | 2017-04-28 |
| MUH | 3 | 2014-07-30 |
| EHD | 3 | 2005-01-13 |
| PEM | 2 | 2024-05-09 |
| EBF | 2 | 2012-09-28 |
| NJM | 2 | 2011-01-25 |
| EBC | 2 | 2010-12-03 |
| KLE | 2 | 2010-11-23 |
| EKR | 2 | 2006-06-05 |
| LYZ | 2 | 2003-08-14 |
| KOJ | 2 | 2002-02-19 |
| ELC | 2 | 2001-06-05 |
| DZB | 2 | 2000-06-09 |
| DYW | 1 | 2025-04-21 |
| KJJ | 1 | 2021-09-09 |
| JOJ | 1 | 2018-02-22 |
| OAS | 1 | 2016-02-04 |
| EBG | 1 | 2011-02-04 |
| EFB | 1 | 2007-10-12 |
| FRC | 1 | 2004-05-25 |
| MSH | 1 | 2002-07-23 |
| DYH | 1 | 2001-10-24 |
| EFQ | 1 | 1994-02-02 |
Stannous Fluoride
Stannous Fluoride
YOUNG INNOVATIONS LLC DBA PLAK SMACKER
YOUNG INNOVATIONS LLC DBA PLAK SMACKER
2026-05-11
2022-10-18
2022-10-18
2022-10-18
2022-10-18
2025-03-17
2025-03-17
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2026-04-20
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