Atlas FDA

Clinpro Varnish

FDA 510(k) clearance K151302 · decided 2015-09-18

Clearance details

K-number
K151302
Device name
Clinpro Varnish
Applicant
3M Company
Decision
Substantially Equivalent
Date received
2015-05-15
Decision date
2015-09-18
Days to decision
126 days
Clearance type
Traditional
Product code
LBH
Device class
2
Regulation number
872.3260
Medical specialty
Dental
Advisory committee
Dental
Location
Saint Paul, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Fluoride Varnish (Type A,Type C) (K253052)Nagy Oral Technology Qinhuangdao Co., Ltd.2026-06-11
VOCO Profluorid Varnish + BioMin (K252073)Voco GmbH2026-05-01
UltraEZ (K261404)Ultradent Products, Inc.2026-04-30
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (K260830)Sangi Co., Ltd.2026-03-18
FluoroDose Varnish (K250714)Centrix, Inc.2025-11-21
Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777)Theodent, LLC2025-05-27
ReminGel (K241489)Inter-Med, Inc.2025-01-08
CrystLCare™ PRO Biorestorative, Fluoride-Plus (K241568)GreenMark Biomedical, Inc.2025-01-02
Jasmate® Toothpaste (K242913)Jasberry Healthcare Private Limited2024-11-22
Papacarie Duo (K233768)Elevate Oral Care2024-07-18
ProMin Dental Desensitizing Gel (K231060)Belport Company, Inc., Gingi-Pak2024-06-13
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333)Kettenbach GmbH & Co. KG2023-07-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22