Elevate Oral Care

FDA Filings

This page includes the latest FDA filings for Elevate Oral Care. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009603151
• FEI Number: 3009603151
• Name: ELEVATE ORAL CARE, LLC
• Owner & Operator: Elevate Oral Care
• Contact Address: 346 Pike Road Suite 5; West Palm Beach FL 33411 US
• Official Correspondent:
  • Richard Krone
  • 1-877-8669113-103
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 346 Pike Rd Ste 5 ; West Palm Beach, FL 33411 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
Allday 5000 Elevate Oral Care	Prescription Medication	2025-09-25
Stance Elevate Oral Care	Otc Medication	2025-09-25
Stance Elevate Oral Care	Otc Medication	2025-09-24
Povi-One Elevate Oral Care	Otc Medication	2025-09-21
FluoriMax 5000 Sensitive Elevate Oral Care	Prescription Medication	2025-09-21
FluoriMax 5000 Elevate Oral Care	Prescription Medication	2025-09-21
Just Right 5000 Elevate Oral Care	Prescription Medication	2025-09-21
Just Right 5000 Elevate Oral Care	Prescription Medication	2025-09-21
Just Right 5000 Elevate Oral Care	Prescription Medication	2025-09-21
Povi-One Elevate Oral Care	Otc Medication	2025-09-21
Povi-One Elevate Oral Care	Otc Medication	2025-07-09
Povi-One Elevate Oral Care	Otc Medication	2025-05-07
Povi-One Elevate Oral Care	Otc Medication	2024-12-15
Just Right 5000 Elevate Oral Care	Otc Medication	2024-12-15
FluoriMax 5000 Elevate Oral Care	Otc Medication	2024-12-15
Just Right 5000 Elevate Oral Care	Otc Medication	2024-12-15
Just Right Elevate Oral Care	Otc Medication	2024-12-15
Povi-One Elevate Oral Care	Otc Medication	2024-12-13
Allday 5000 Elevate Oral Care	Prescription Medication	2024-02-23
Povi-One Elevate Oral Care	Otc Medication	2023-10-31
Stance Elevate Oral Care	Otc Medication	2023-10-31
Stance Elevate Oral Care	Otc Medication	2023-10-31
Povi-One Elevate Oral Care	Otc Medication	2023-03-01
Just Right 5000 Elevate Oral Care	Prescription Medication	2022-11-01
FluoriMax 5000 Sensitive Elevate Oral Care	Otc Medication	2022-11-01
Stance Elevate Oral Care	Otc Medication	2022-11-01
Stance Elevate Oral Care	Otc Medication	2022-11-01
FluoriMax 5000 Sensitive Elevate Oral Care	Prescription Medication	2022-06-15
FluoriMax 5000 Elevate Oral Care	Prescription Medication	2022-06-15
NDC 57511-0005 Elevate Oral Care	Allday 5000	2022-05-31
Allday 5000 Elevate Oral Care	Prescription Medication	2022-05-31
NDC 57511-0610 Elevate Oral Care	Povi-One	2022-05-02
Povi-One Elevate Oral Care	Otc Medication	2022-05-02
Just Right 5000 Elevate Oral Care	Otc Medication	2021-11-03
Just Right 5000 Elevate Oral Care	Otc Medication	2021-11-03
Just Right 5000 Elevate Oral Care	Otc Medication	2021-11-03
FluoriMax 5000 Elevate Oral Care	Otc Medication	2021-10-23
Just Right 5000 Elevate Oral Care	Prescription Medication	2021-02-09
Just Right 5000 Elevate Oral Care	Prescription Medication	2021-02-09
Just Right 5000 Elevate Oral Care	Prescription Medication	2021-02-09
Just Right 5000 Elevate Oral Care	Otc Medication	2021-02-09
Just Right 5000 Elevate Oral Care	Otc Medication	2021-02-09
Just Right 5000 Elevate Oral Care	Otc Medication	2021-02-09
FluoriMax 5000 Elevate Oral Care	Prescription Medication	2020-09-02
FluoriMax 5000 Sensitive Elevate Oral Care	Prescription Medication	2020-09-02
NDC 57511-0504 Elevate Oral Care	FluoriMax 5000	2020-09-01
NDC 57511-0503 Elevate Oral Care	FluoriMax 5000 Sensitive	2020-08-31
Just Right 5000 Elevate Oral Care	Prescription Medication	2020-08-29
Just Right 5000 Elevate Oral Care	Prescription Medication	2020-08-29
NDC 57511-0003 Elevate Oral Care	Just Right 5000	2020-08-28
NDC 57511-0002 Elevate Oral Care	Just Right 5000	2020-08-28
Just Right 5000 Elevate Oral Care	Prescription Medication	2020-08-28
NDC 57511-0001 Elevate Oral Care	Just Right 5000	2020-08-05
Just Right 5000 Elevate Oral Care	Otc Medication	2020-06-02
Just Right 5000 Elevate Oral Care	Otc Medication	2020-06-02
Just Right 5000 Elevate Oral Care	Otc Medication	2020-06-02
PMN K093059 | EBC ELEVATE ORAL CARE, LLC [Elevate Oral Care]	DenteShield Surface Sealant	2020-02-11
PMN K093059 | EBC ELEVATE ORAL CARE, LLC [Elevate Oral Care]	DenteShield Pit and Fissure Sealant	2020-02-11
PMN K080445 | DYH ELEVATE ORAL CARE, LLC [Elevate Oral Care]	DenteShield Primer	2020-02-11
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-24
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-24
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-24
FluoriMax 5000 Sensitive Elevate Oral Care	Otc Medication	2020-01-24
Stance Elevate Oral Care	Otc Medication	2020-01-24
Stance Elevate Oral Care	Otc Medication	2020-01-24
NDC 57511-0122 Elevate Oral Care	Just Right 5000	2020-01-01
NDC 57511-0108 Elevate Oral Care	Just Right 5000	2020-01-01
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-01
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-01
Just Right 5000 Elevate Oral Care	Otc Medication	2020-01-01
Stance Elevate Oral Care	Otc Medication	2019-10-25
Stance Elevate Oral Care	Otc Medication	2019-10-25
FluoriMax 5000 Sensitive Elevate Oral Care	Otc Medication	2019-10-10
Just Right Elevate Oral Care	Otc Medication	2019-10-10
PMN K895386 | EMA ELEVATE ORAL CARE, LLC [Elevate Oral Care]	SMART Advantage	2019-05-31
PMN K850915 | EGD ELEVATE ORAL CARE, LLC [Elevate Oral Care]	Toothprint Wafer	2019-01-23
FluoriMax 5000 Elevate Oral Care	Otc Medication	2019-01-09
Just Right 5000 Elevate Oral Care	Otc Medication	2019-01-09
Just Right 5000 Elevate Oral Care	Otc Medication	2019-01-09
PMN K150074 | LFD ELEVATE ORAL CARE, LLC [Elevate Oral Care]	Allday	2018-09-12
NDC 57511-0120 Elevate Oral Care	Just Right 5000	2018-01-01
NDC 57511-0119 Elevate Oral Care	Just Right 5000	2018-01-01
NDC 57511-0102 Elevate Oral Care	FluoriMax 5000 Sensitive	2017-08-01
NDC 57511-0202 Elevate Oral Care	Stance	2016-08-25
NDC 57511-0201 Elevate Oral Care	Stance	2016-08-25
PMN K150074 ELEVATE ORAL CARE	Elevate Moisturizing Spray	2015-06-19
PMN K102973 | PHR ELEVATE ORAL CARE, LLC [Elevate Oral Care]	Advantage Arrest	2015-04-22
LCN ELEVATE ORAL CARE, LLC [Elevate Oral Care]	Epic Tongue Cleaner	2015-03-12
EJR ELEVATE ORAL CARE, LLC [Elevate Oral Care]	Dualpro Desensitizing Prophylaxis Paste	2015-03-12
NDC 57511-0101 Elevate Oral Care	FluoriMax 5000	2015-02-01
PMN K131376 | LBH ELEVATE ORAL CARE, LLC [Elevate Oral Care]	FluoriMax	2014-09-15
PMN K131376 ELEVATE ORAL CARE	SMARTCOAT 2.5% NAF VARNISH	2013-08-27
NDC 57511-0124 Elevate Oral Care	Just Right	2013-05-07

Similar & Related FDA Registered Companies

• ELEVATE ORAL CARE, LLC