Amelogen Plus

510(k) K043119

Amelogen Plus is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K043119 on 17 Dec 2004, 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) K043119↗

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 · Special	NumberK043119	Date17 Dec 2004Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K043119

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K043119
FDA product code: EBF

Device class: Class II
Regulation: 21 CFR Part 872.3690
Advisory committee: Dental
FDA decision: SESE Substantially Equivalent

Devices cleared under K043119

74 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 K043119
		UDI-DI	Size and differences
Amelogen Plus 3013 ULTRADENT PRODUCTS, INC.	3013 / 3013	00883205106544	Single use: no	No longer on the market
Amelogen Plus 3098 ULTRADENT PRODUCTS, INC.	3098 / 3098	00883205036926	Single use: no	On the market
Amelogen Plus 3098 ULTRADENT PRODUCTS, INC.	3098 / 3098	00883205027313	Single use: no	On the market
Amelogen Plus 3098 ULTRADENT PRODUCTS, INC.	3098 / 3098	00883205106612	Single use: no	On the market
Amelogen Plus 315 ULTRADENT PRODUCTS, INC.	315 / 315	00883205105516	Single use: no	On the market
Amelogen Plus 3209 ULTRADENT PRODUCTS, INC.	3209 / 3209	00883205106650	Single use: no	No longer on the market
Amelogen Plus 3254 ULTRADENT PRODUCTS, INC.	3254 / 3254	00883205106667	Single use: no	No longer on the market
Amelogen Plus 4525 ULTRADENT PRODUCTS, INC.	4525 / 4525	00883205106681	Single use: yes	No longer on the market
Amelogen Plus 8010 ULTRADENT PRODUCTS, INC.	8010 / 8010	00883205036957	Single use: yes	On the market
Amelogen Plus 8011 ULTRADENT PRODUCTS, INC.	8011 / 8011	00883205106919	Single use: yes	On the market
Amelogen Plus 8012 ULTRADENT PRODUCTS, INC.	8012 / 8012	00883205036971	Single use: yes	On the market
Amelogen Plus 8013 ULTRADENT PRODUCTS, INC.	8013 / 8013	00883205106933	Single use: yes	On the market
Amelogen Plus 8013 ULTRADENT PRODUCTS, INC.	8013 / 8013	00883205036988	Single use: yes	On the market
Amelogen Plus 8015 ULTRADENT PRODUCTS, INC.	8015 / 8015	00883205037008	Single use: yes	On the market
Amelogen Plus 8015 ULTRADENT PRODUCTS, INC.	8015 / 8015	00883205106957	Single use: yes	On the market
Amelogen Plus 8016 ULTRADENT PRODUCTS, INC.	8016 / 8016	00883205106964	Single use: yes	On the market
Amelogen Plus 8017 ULTRADENT PRODUCTS, INC.	8017 / 8017	00883205106971	Single use: yes	On the market
Amelogen Plus 8018 ULTRADENT PRODUCTS, INC.	8018 / 8018	00883205106988	Single use: yes	On the market
Amelogen Plus 8018 ULTRADENT PRODUCTS, INC.	8018 / 8018	00883205037039	Single use: yes	On the market
Amelogen Plus 8020 ULTRADENT PRODUCTS, INC.	8020 / 8020	00883205107008	Single use: yes	On the market
Amelogen Plus 8020 ULTRADENT PRODUCTS, INC.	8020 / 8020	00883205037053	Single use: yes	On the market
Amelogen Plus 8021 ULTRADENT PRODUCTS, INC.	8021 / 8021	00883205107015	Single use: yes	On the market
Amelogen Plus 8022 ULTRADENT PRODUCTS, INC.	8022 / 8022	00883205037077	Single use: yes	On the market
Amelogen Plus 8023 ULTRADENT PRODUCTS, INC.	8023 / 8023	00883205037084	Single use: yes	On the market
Amelogen Plus 8023 ULTRADENT PRODUCTS, INC.	8023 / 8023	00883205107039	Single use: yes	On the market
Amelogen Plus 8024 ULTRADENT PRODUCTS, INC.	8024 / 8024	00883205037091	Single use: yes	On the market
Amelogen Plus 8024 ULTRADENT PRODUCTS, INC.	8024 / 8024	00883205107046	Single use: yes	On the market
Amelogen Plus 8026 ULTRADENT PRODUCTS, INC.	8026 / 8026	00883205037107	Single use: yes	On the market
Amelogen Plus 9028 ULTRADENT PRODUCTS, INC.	9028 / 9028	00883205107091	Single use: no	On the market
Amelogen Plus 9028 ULTRADENT PRODUCTS, INC.	9028 / 9028	00883205037114	Single use: no	On the market
Amelogen Plus 9031 ULTRADENT PRODUCTS, INC.	9031 / 9031	00883205037138	Single use: no	On the market
Amelogen Plus 9031 ULTRADENT PRODUCTS, INC.	9031 / 9031	00883205107114	Single use: no	On the market
Amelogen Plus 9032 ULTRADENT PRODUCTS, INC.	9032 / 9032	00883205037145	Single use: no	On the market
Amelogen Plus 9032 ULTRADENT PRODUCTS, INC.	9032 / 9032	00883205107121	Single use: no	On the market
Amelogen Plus 9033 ULTRADENT PRODUCTS, INC.	9033 / 9033	00883205107138	Single use: no	On the market
Amelogen Plus 9033 ULTRADENT PRODUCTS, INC.	9033 / 9033	00883205037152	Single use: no	On the market
Amelogen Plus 9034 ULTRADENT PRODUCTS, INC.	9034 / 9034	00883205107145	Single use: no	On the market
Amelogen Plus 9035 ULTRADENT PRODUCTS, INC.	9035 / 9035	00883205107152	Single use: no	On the market
Amelogen Plus 9036 ULTRADENT PRODUCTS, INC.	9036 / 9036	00883205037183	Single use: no	On the market
Amelogen Plus 9036 ULTRADENT PRODUCTS, INC.	9036 / 9036	00883205107169	Single use: no	On the market
Amelogen Plus 9037 ULTRADENT PRODUCTS, INC.	9037 / 9037	00883205037190	Single use: no	On the market
Amelogen Plus 9038 ULTRADENT PRODUCTS, INC.	9038 / 9038	00883205107183	Single use: no	On the market
Amelogen Plus 9038 ULTRADENT PRODUCTS, INC.	9038 / 9038	00883205037206	Single use: no	On the market
Amelogen Plus 9039 ULTRADENT PRODUCTS, INC.	9039 / 9039	00883205037213	Single use: no	On the market
Amelogen Plus 9039 ULTRADENT PRODUCTS, INC.	9039 / 9039	00883205107190	Single use: no	On the market
Amelogen Plus 9040 ULTRADENT PRODUCTS, INC.	9040 / 9040	00883205037220	Single use: no	On the market
Amelogen Plus 9041 ULTRADENT PRODUCTS, INC.	9041 / 9041	00883205107213	Single use: no	On the market
Amelogen Plus 9042 ULTRADENT PRODUCTS, INC.	9042 / 9042	00883205037244	Single use: no	On the market
Amelogen Plus 9042 ULTRADENT PRODUCTS, INC.	9042 / 9042	00883205107220	Single use: no	On the market
Amelogen Plus S3020 ULTRADENT PRODUCTS, INC.	S3020 / S3020	00883205037268	Single use: no	On the market

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Regulatory status

Coverage

Specification

Related clearances

Cited by

Devices cleared under K043119

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