Company · US
Church & Dwight Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2025. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2025 | K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) Church & Dwight Co., Inc. | HIS |
| Oct 8, 2024 | K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant Church & Dwight Co., Inc. | MOL |
| Sep 28, 2022 | K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom Church & Dwight Co., Inc. | HIS |
| Jul 14, 2022 | K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant Church & Dwight Co., Inc. | HIS |
| Jun 11, 2021 | K203818 | Replens Long-Lasting Vaginal Moisturizer Church & Dwight Co., Inc. | NUC |
| Jul 23, 2020 | K193450 | Pre-Seed Fertility Lubricant Church & Dwight Co., Inc. | PEB |
| Aug 1, 2018 | K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Church & Dwight Co., Inc. | NUC |
| Mar 14, 2018 | K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant Church & Dwight Co., Inc. | HIS |
| Aug 1, 2017 | K171639 | Trojan Supra Lubricated Polyurethane Male Condom Church & Dwight Co., Inc. | MOL |
| Sep 9, 2016 | K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant Church & Dwight Co., Inc. | HIS |
| Aug 31, 2016 | K161544 | Trojan Chain Reaction Personal Lubricant Church & Dwight Co., Inc. | NUC |
| Aug 26, 2016 | K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant Church & Dwight Co., Inc. | HIS |
| Jul 20, 2015 | K150886 | Trojan Riviera Personal Lubricant Church & Dwight Co., Inc. | NUC |
| Jul 21, 2014 | K141034 | AZUL PERSONAL LUBRICANT Church & Dwight Co., Inc. | NUC |
| Oct 24, 2013 | K131887 | TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT Church & Dwight Co., Inc. | HIS |
| Sep 10, 2013 | K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST Church & Dwight Co., Inc. | LCX |
| Aug 26, 2013 | K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST Church & Dwight Co., Inc. | LCX |
| Jun 28, 2013 | K123427 | NIRVANA D PERSONAL LUBRICANT (TBD) Church & Dwight Co., Inc. | NUC |
| Oct 4, 2012 | K120706 | NIRVANA A PERSONAL LUBRICANT Church & Dwight Co., Inc. | NUC |
| Oct 3, 2012 | K120751 | NIRVANA B PERSONAL LUBRICANT Church & Dwight Co., Inc. | NUC |
| Jun 19, 2012 | K120286 | TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT Church & Dwight Co., Inc. | HIS |
| May 16, 2012 | K120287 | TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT Church & Dwight Co., Inc. | HIS |
| Apr 5, 2011 | K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. | MOL |
| Jun 8, 2009 | K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) Church & Dwight Co., Inc. | LCX |
| Nov 9, 2007 | K073016 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT Church & Dwight Co., Inc. | HIS |
| Oct 26, 2007 | K071313 | TROJAN-ENZ BRAND Church & Dwight Co., Inc. | HIS |
| Sep 12, 2007 | K071272 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM Church & Dwight Co., Inc. | HIS |
| May 4, 2007 | K070054 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST Church & Dwight Co., Inc. | LCX |
| Feb 28, 2006 | K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM Church & Dwight Co., Inc. | MOL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2023 | Church & Dwight Inc Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e Open, Classified |
LCX | K083716 |
| Jul 25, 2013 | Church & Dwight Inc Sodium Bicarbonate, USP
Provided bulk as raw material - label not applicable according to firm
Dialysis Grade 1.5
Dialysis Grade 2
As an API or excipient in the manufacture of Medical Devices and D Terminated |
None listed | |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening
Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge
Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque removal. Terminated |
JEQ | None listed |
| Jan 25, 2012 | Church & Dwight Inc Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models.
Made in China.
Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.
For dental health; plaque remov Terminated |
JEQ | None listed |