Who else makes this device?

Name: Aelite Aesthetic Enamel
Brand: Aelite Aesthetic Enamel

Aelite Aesthetic Enamel · Material, Tooth Shade, Resin → Dental

10manufacturers in China registered for this device type

84catalogue numbers in this listing

30510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (3), Shandong (2), Jilin (2).

Chinese manufacturers registered for FDA product code EBF
Manufacturer	City	Province	Registered as	Device types
Aidite (Qinhuangdao) Technology Co., Ltd.	Qinhuangdao	Hebei	Repacker / relabeller	17
Shandong Huge Dental Material Corporation	Rizhao	Shandong	Manufacturer	17
Liaoning Upcera Co., Ltd.	Benxi	Liaoning	Contract manufacturer	10
Shenzhen Upcera Digital Dental Technology Co., Ltd.	Shenzhen	Guangdong	Exporter	10
Rizhao Huge Biomaterials Company, Ltd.	Rizhao	Shandong	Manufacturer	7
Hangzhou SHINING3D Dental Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	7
Shenzhen Piocreat 3D Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6
Shenzhen Upcera Dental Technology Co., Ltd.	Shenzhen	Guangdong	Private-label distributor	6
Sincera Technology (Changchun) Co., Ltd.	Changchun	Jilin	Manufacturer	2
Sino-Dentex Co., Ltd.	Changchun	Jilin	Manufacturer	2

Record

Regulatory record for Aelite Aesthetic Enamel
Listed by	Bisco, Inc., United States
FDA product code	EBF
Device type	Material, Tooth Shade, Resin
Device class	Class 2
Regulation	21 CFR 872.3690
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2017-06-12
Record revised	2023-01-17 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 20 to 25 °C
Packaging	Item no: h-852a3p, item no: h-854d2p, item no: h-854b1p, item no: h-852d2p, item no: h-852a4p, item no: h-852a35p
Distribution end date	2025-04-15

Catalogue Numbers

Catalogue numbers for Aelite Aesthetic Enamel
Catalogue number	Per pack	Status
H-852A3		In distribution
H-854A1	15	In distribution
H-854B1	15	In distribution
H-852A35		In distribution
H-852A1		In distribution
H-852W2		In distribution
H-854B2	15	In distribution
H-854A35	15	In distribution
H-854CL	15	In distribution
H-852B2		In distribution
H-852B1		In distribution
H-854A3	15	In distribution
H-854W2	15	In distribution
H-852CL		In distribution
H-852A2		In distribution
H-854A2	15	In distribution
H-854B2P		Withdrawn
H-854B3		Withdrawn
H-852B4P		Withdrawn
H-852D2		Withdrawn
H-852D4P		Withdrawn
H-854D2	15	Withdrawn
H-852A2P		Withdrawn
H-852B2		Withdrawn
H-852B1P		Withdrawn
H-852D2		Withdrawn
H-854B4P		Withdrawn
H-852A4		Withdrawn
H-852FR		Withdrawn
H-854A1		Withdrawn
H-852W2		Withdrawn
H-854A35P		Withdrawn
H-854D4P		Withdrawn
H-854A4		Withdrawn
H-854B4	15	Withdrawn
H-852D4		Withdrawn
H-854A1P		Withdrawn
H-854A4	15	Withdrawn
H-852A3P		Withdrawn
H-854CLP		Withdrawn
H-854A3P		Withdrawn
H-854B1		Withdrawn
H-852B3		Withdrawn
H-854FR	15	Withdrawn
H-854W2		Withdrawn
H-854B1P		Withdrawn
H-854B3P		Withdrawn
H-852A3		Withdrawn
H-854A2P		Withdrawn
H-854D4	15	Withdrawn
H-852A4		Withdrawn
H-852B3		Withdrawn
H-852W2P		Withdrawn
H-852FRP		Withdrawn
H-852A1P		Withdrawn
H-852CL		Withdrawn
H-852D4		Withdrawn
H-854D2		Withdrawn
H-854W2P		Withdrawn
H-854B2		Withdrawn
H-854FR		Withdrawn
H-852B4		Withdrawn
H-852D2P		Withdrawn
H-852A1		Withdrawn
H-852A35		Withdrawn
H-852B3P		Withdrawn
H-852FR		Withdrawn
H-854A35		Withdrawn
H-852B4		Withdrawn
H-854FRP		Withdrawn
H-852B1		Withdrawn
H-852A2		Withdrawn
H-854D2P		Withdrawn
H-854A2		Withdrawn
H-854A3		Withdrawn
H-854B4		Withdrawn
H-852A35P		Withdrawn
H-852CLP		Withdrawn
H-854B3	15	Withdrawn
H-852A4P		Withdrawn
H-854A4P		Withdrawn
H-852B2P		Withdrawn
H-854CL		Withdrawn
H-854D4		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tooth Shade Resin Material	Liaoning Upcera Co., Ltd.	4,808
Gradia®	GC America Inc.	548
G-CAM	Graphenano Dental, SL	320
Vitavm LC	Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft	261
G-aenial™	GC America Inc.	225
Ena HRI ®	Micerium SPA	221
Mazic Duro	Vericom Co., Ltd.	206
Ceramage	Shofu Dental Corp.	204
Filtek™	3M Company	188
SR Nexco	Ivoclar Vivadent Aktiengesellschaft	181
Aidite	Aidite (Qinhuangdao) Technology Co., Ltd.	166
Tetric EvoCeram	Ivoclar Vivadent Aktiengesellschaft	163

Showing 12 of 2,059. All products under Material, Tooth Shade, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242816	2024-12-17
K171147	2017-08-04
K093470	2010-02-17
K042804	2005-02-01
K030951	2003-06-06
K012180	2001-09-05
K010196	2001-04-05
K003361	2000-11-28
K003317	2000-11-21
K993488	1999-11-10
K993192	1999-10-27
K992248	1999-08-25
K984112	1998-12-22
K982729	1998-09-15
K982645	1998-09-02
K974483	1998-02-09
K964931	1997-02-10
K955292	1995-12-13
K934247	1993-11-29
K930405	1993-08-24
K924151	1992-12-28
K921439	1992-05-11
K915668	1992-04-21
K882915	1988-08-12
K875313	1988-03-10
K875256	1988-02-26
K861148	1986-04-30
K853001	1985-08-16
K853002	1985-08-16
K842087	1984-07-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Aelite Aesthetic Enamel