Preventech Prophylaxis Paste with Fluoride

510(k) K100539

Preventech Prophylaxis Paste with Fluoride is a medical device (FDA Class I; FDA product code EJR, Agent, Polishing, Abrasive, Oral Cavity) made by Preventive Technologies, Inc., cleared under FDA 510(k) K100539 on 17 Jun 2010, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K100539↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK100539	Date17 Jun 2010Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K100539

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K100539
FDA product code: EJR

Device class: Class I
Regulation: 21 CFR Part 872.6030
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent

Devices cleared under K100539

65 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K100539
		UDI-DI	Size and differences
MAXMIN Coarse Bubblegum Prophy Paste with NuFluor Box 200 440103 Preventech	440103 / 440103	D024440103	—	On the market
MAXMIN Coarse Cherry Prophy Paste with NuFluor Box 200 440073 Preventech	440073 / 440073	D024440073	—	On the market
MAXMIN Coarse Mint Prophy Paste with NuFluor Box 200 440033 Preventech	440033 / 440033	D024440033	—	On the market
MAXMIN Coarse Orange Vanilla Prophy Paste with NuFluor Box 200 440363 Preventech	440363 / 440363	D024440363	—	On the market
MAXMIN Medium Bubblegum Prophy Paste with NuFluor Box 200 440093 Preventech	440093 / 440093	D024440093	—	On the market
MAXMIN Medium Orange Vanilla Prophy Paste with NuFluor Box 200 440353 Preventech	440353 / 440353	D024440353	—	On the market
NEXT Coarse Adult Variety Prophy Paste Box 200 221143 Preventech	221143 / 221143	D024221143	—	On the market
NEXT Coarse Bubblegum Prophy Paste Box 200 220103 Preventech	220103 / 220103	D024220103	—	On the market
NEXT Coarse Chocolate Mint Prophy Paste Box 200 220153 Preventech	220153 / 220153	D024220153	—	On the market
NEXT Coarse Cinnamon Prophy Paste Box 200 220173 Preventech	220173 / 220173	D024220173	—	On the market
NEXT Coarse Fruit Variety Prophy Paste Box 200 221193 Preventech	221193 / 221193	D024221193	—	On the market
NEXT Coarse Grape Prophy Paste Box 200 220343 Preventech	220343 / 220343	D024220343	—	On the market
NEXT Coarse Mint Prophy Paste Box 200 220033 Preventech	220033 / 220033	D024220033	—	On the market
NEXT Coarse Orange Vanilla Prophy Paste Box 200 220433 Preventech	220433 / 220433	D024220433	—	On the market
NEXT Coarse Raspberry Prophy Paste Box 200 220403 Preventech	220403 / 220403	D024220403	—	On the market
NEXT Coarse Spearmint Prophy Paste Box 200 220303 Preventech	220303 / 220303	D024220303	—	On the market
NEXT Coarse Strawberry Prophy Paste Box 200 220373 Preventech	220373 / 220373	D024220373	—	On the market
NEXT Coarse Vanilla Prophy Paste Box 200 220233 Preventech	220233 / 220233	D024220233	—	On the market
NEXT Coarse Watermelon Prophy Paste Box 200 220203 Preventech	220203 / 220203	D024220203	—	On the market
NEXT Extra Coarse Mint Prophy Paste Box 200 220043 Preventech	220043 / 220043	D024220043	—	On the market
NEXT Extra Coarse Spearmint Prophy Paste Box 200 220313 Preventech	220313 / 220313	D024220313	—	On the market
NEXT Extra Coarse Wintergreen Prophy Paste Box 200 220273 Preventech	220273 / 220273	D024220273	—	On the market
NEXT Fine Bubblegum Prophy Paste Box 200 220083 Preventech	220083 / 220083	D024220083	—	On the market
NEXT Fine Cherry Prophy Paste Box 200 220053 Preventech	220053 / 220053	D024220053	—	On the market
NEXT Fine Mint Prophy Paste Box 200 220013 Preventech	220013 / 220013	D024220013	—	On the market
NEXT Fine Spearmint Prophy Paste Box 200 220283 Preventech	220283 / 220283	D024220283	—	On the market
NEXT Fine Tropical Fruit Prophy Paste Box 200 220113 Preventech	220113 / 220113	D024220113	—	On the market
NEXT Fine Vanilla Prophy Paste Box 200 220213 Preventech	220213 / 220213	D024220213	—	On the market
NEXT Fine Wintergreen Prophy Paste Box 200 220243 Preventech	220243 / 220243	D024220243	—	On the market
NEXT Medium Adult Variety Prophy Paste Box 200 221133 Preventech	221133 / 221133	D024221133	—	On the market
NEXT Medium Bubblegum Prophy Paste Box 200 220093 Preventech	220093 / 220093	D024220093	—	On the market
NEXT Medium Cherry Prophy Paste Box 200 220063 Preventech	220063 / 220063	D024220063	—	On the market
NEXT Medium Chocolate Mint Prophy Paste Box 200 220143 Preventech	220143 / 220143	D024220143	—	On the market
NEXT Medium Cinnamon Prophy Paste Box 200 220163 Preventech	220163 / 220163	D024220163	—	On the market
NEXT Medium Fruit Variety Prophy Paste Box 200 221183 Preventech	221183 / 221183	D024221183	—	On the market
NEXT Medium Grape Prophy Paste Box 200 220333 Preventech	220333 / 220333	D024220333	—	On the market
NEXT Medium Orange Vanilla Prophy Paste Box 200 220423 Preventech	220423 / 220423	D024220423	—	On the market
NEXT Medium Spearmint Prophy Paste Box 200 220293 Preventech	220293 / 220293	D024220293	—	On the market
NEXT Medium Strawberry Prophy Paste Box 200 220363 Preventech	220363 / 220363	D024220363	—	On the market
NEXT Medium Vanilla Prophy Paste Box 200 220223 Preventech	220223 / 220223	D024220223	—	On the market
NEXT Medium Watermelon Prophy Paste Box 200 220193 Preventech	220193 / 220193	D024220193	—	On the market
NEXT Medium Wintergreen Prophy Paste Box 200 220253 Preventech	220253 / 220253	D024220253	—	On the market
PIVOT Coarse Kid's Variety Prophy Pack Box 100 1100123 Preventech	1100123 / 1100123	D0241100123	—	On the market
PIVOT Coarse Mint Prophy Pack Box 100 1100083 Preventech	1100083 / 1100083	D0241100083	—	On the market
PIVOT Extra Coarse Mint Prophy Pack Box 100 1100093 Preventech	1100093 / 1100093	D0241100093	—	On the market
PIVOT Fine Cherry Prophy Pack Box 100 1100063 Preventech	1100063 / 1100063	D0241100063	—	On the market
PIVOT Medium Adult Variety Prophy Pack Box 100 1100133 Preventech	1100133 / 1100133	D0241100133	—	On the market
PIVOT Medium Bubblegum Prophy Pack Box 100 1100103 Preventech	1100103 / 1100103	D0241100103	—	On the market
PIVOT Medium Mint Prophy Pack Box 100 1100073 Preventech	1100073 / 1100073	D0241100073	—	On the market
PIVOT Nada Pumice Paste Prophy Pack Box 100 1100153 Preventech	1100153 / 1100153	D0241100153	—	On the market

Similar devices

Other devices filed under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity).

Other devices from Preventive Technologies, Inc.

Vella 5% Sodium Fluoride Varnish with NuFluor and Xylitol

Class II
Disposable Prophylaxis Angle

Class I

Regulatory status

Coverage

Specification

Related clearances

Cites

Devices cleared under K100539

Similar devices

Other devices from Preventive Technologies, Inc.

Vella 5% Sodium Fluoride Varnish with NuFluor and Xylitol

Disposable Prophylaxis Angle