Who else makes this device?

Name: Biotone® Plastic Anteriors
Brand: Biotone® Plastic Anteriors

Biotone® Plastic Anteriors · Denture, Plastic, Teeth → Dental

26manufacturers in China registered for this device type

460catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELM
Manufacturer	City	Province	Registered as	Device types
Shenzhen Jiahong Dental Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	7
Debo Medical Technology (Shijiazhuang) Co., Ltd.	Shijiazhuang	Hebei	Contract manufacturer	117
Wuxi Lyusmile IMP AND EXP Co., Ltd.	Wuxi	Jiangsu	Private-label distributor	66
Dongguan Wanjin Industrial Co., Ltd.	Dongguang	Guangdong	Remanufacturer	41
Fuzhou Delphin BIO-Tech Co., Ltd.	Fuzhou	Fujian	Manufacturer	18
Shandong Huge Dental Material Corporation	Rizhao	Shandong	Manufacturer	17
Shenzhen Sunmc Dental Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	17
Improve Co., Limited	Lantau Island	Hong Kong	Contract manufacturer	16
Shanghai Fanta Dental Materials Co., Ltd.	Shanghai	Shanghai	Manufacturer	15
Heyuan HEY White Technology Co., Ltd.	Heyuan	Guangdong	Manufacturer	12
Beijing Yingguan Dental Science&Technology Co., Ltd.	Beijing	Beijing	Manufacturer	11
Smile Dental Laboratory Company Limited	Zhuhai	Guangdong	Manufacturer	11

Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth

Record

Regulatory record for Biotone® Plastic Anteriors
Listed by	Dentsply LLC, United States
FDA product code	ELM
Device type	Denture, Plastic, Teeth
Device class	Class 2
Regulation	21 CFR 872.3590
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-10-10
Record revised	2022-05-05 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number
Distribution end date	2022-05-05

Catalogue Numbers

Catalogue numbers for Biotone® Plastic Anteriors
Catalogue number	Size	Status
66 L 4H		Withdrawn
61 U 1B		Withdrawn
81 L 3N		Withdrawn
67 U 4H		Withdrawn
69 U 2N		Withdrawn
77 U 3N		Withdrawn
68 U 2D		Withdrawn
59 U 3P		Withdrawn
62 L 3P		Withdrawn
59 U 137		Withdrawn
65 U A25		Withdrawn
69 U 3D		Withdrawn
61 U 2P		Withdrawn
65 L 1H		Withdrawn
77 U 268		Withdrawn
68 U A23		Withdrawn
59 U A24		Withdrawn
65 L 3D		Withdrawn
77 L 3D		Withdrawn
66 U A25		Withdrawn
59 U 1N		Withdrawn
81 L 1H		Withdrawn
62 U 267		Withdrawn
66 L 1H		Withdrawn
77 U A25		Withdrawn
67 L 2E		Withdrawn
67 U 266		Withdrawn
81 U 263		Withdrawn
69 U 133		Withdrawn
81 U 2D		Withdrawn
62 L 2D		Withdrawn
69 L 2C		Withdrawn
67 U 4M		Withdrawn
67 L 3P		Withdrawn
59 U A26		Withdrawn
66 U 1N		Withdrawn
69 U 1B		Withdrawn
61 U 263		Withdrawn
67 L 1H		Withdrawn
67 U 2D		Withdrawn
65 L 2P		Withdrawn
61 U 267		Withdrawn
67 L 3M		Withdrawn
65 U 4P		Withdrawn
62 U A24		Withdrawn
59 L 1N		Withdrawn
81 U 1H		Withdrawn
61 U A26		Withdrawn
77 U 2P		Withdrawn
65 L 3P		Withdrawn
59 U 4P		Withdrawn
81 L 2D		Withdrawn
62 U 266		Withdrawn
69 L 2N		Withdrawn
68 L 47		Withdrawn
66 L 3P		Withdrawn
59 U 133		Withdrawn
65 L 3N		Withdrawn
77 U 2N		Withdrawn
61 L 2E		Withdrawn
81 U 137		Withdrawn
62 U 3P		Withdrawn
69 L 46		Withdrawn
62 U A84		Withdrawn
62 U 268		Withdrawn
67 U 1H		Withdrawn
77 U 263		Withdrawn
59 U 267		Withdrawn
81 L 46		Withdrawn
61 U A23		Withdrawn
68 U A25		Withdrawn
65 U 1N		Withdrawn
59 U 264		Withdrawn
62 U 1B		Withdrawn
59 L 35		Withdrawn
59 U 2P		Withdrawn
67 U 3P		Withdrawn
68 U 3P		Withdrawn
69 U 136		Withdrawn
61 U 2D		Withdrawn
67 L 1N		Withdrawn
81 L 3R		Withdrawn
67 U 1B		Withdrawn
59 U 4N		Withdrawn
68 U 135		Withdrawn
77 U A26		Withdrawn
61 U 4H		Withdrawn
61 L 2N		Withdrawn
69 U 4M		Withdrawn
67 U 134		Withdrawn
65 U 2D		Withdrawn
59 L 1H		Withdrawn
66 U 268		Withdrawn
67 U 3M		Withdrawn
68 U 1N		Withdrawn
68 L 2C		Withdrawn
66 L 35		Withdrawn
59 U 266		Withdrawn
61 L 1N		Withdrawn
69 U A25		Withdrawn
62 U 2D		Withdrawn
68 U 4P		Withdrawn
68 U 263		Withdrawn
62 U 135		Withdrawn
68 U 4M		Withdrawn
81 L 2N		Withdrawn
61 L 47		Withdrawn
68 L 1H		Withdrawn
62 U A25		Withdrawn
67 U 133		Withdrawn
59 U 4H		Withdrawn
77 L 26		Withdrawn
62 L 3M		Withdrawn
66 U 267		Withdrawn
67 U 3N		Withdrawn
67 U 264		Withdrawn
67 L 2C		Withdrawn
61 U 134		Withdrawn
67 L 3N		Withdrawn
62 L 2P		Withdrawn
61 U 3N		Withdrawn
81 U 4N		Withdrawn
69 L 47		Withdrawn
65 U 2N		Withdrawn
68 L 3P		Withdrawn
59 U A23		Withdrawn
69 U 137		Withdrawn
59 U 3M		Withdrawn
62 U A23		Withdrawn
59 L 3D		Withdrawn
67 L 2D		Withdrawn
61 U A25		Withdrawn
69 L 1N		Withdrawn
68 L 2N		Withdrawn
69 U 4P		Withdrawn
62 U 136		Withdrawn
59 U 135		Withdrawn
59 L 2P		Withdrawn
66 U 3N		Withdrawn
67 U 135		Withdrawn
77 U 136		Withdrawn
61 U 135		Withdrawn
59 L 47		Withdrawn
62 U 133		Withdrawn
62 U A26		Withdrawn
65 U 137		Withdrawn
69 L 3N		Withdrawn
68 L 46		Withdrawn
68 U A84		Withdrawn
66 U 264		Withdrawn
67 U 268		Withdrawn
68 U 3N		Withdrawn
66 L 2P		Withdrawn
69 U A84		Withdrawn
81 U 4P		Withdrawn
81 L 3D		Withdrawn
77 L 2D		Withdrawn
59 L 2E		Withdrawn
77 U A84		Withdrawn
67 U 136		Withdrawn
66 L 3R		Withdrawn
68 L 2P		Withdrawn
81 U A23		Withdrawn
61 L 3N		Withdrawn
65 L 3M		Withdrawn
66 L 1N		Withdrawn
67 U 263		Withdrawn
62 U 4N		Withdrawn
67 L 35		Withdrawn
59 L 3P		Withdrawn
65 L 2E		Withdrawn
67 U A26		Withdrawn
61 L 3M		Withdrawn
69 U 2P		Withdrawn
77 U 3P		Withdrawn
81 L 2P		Withdrawn
62 U 263		Withdrawn
77 U 135		Withdrawn
66 L 2C		Withdrawn
65 U 136		Withdrawn
59 L 4H		Withdrawn
66 L 2N		Withdrawn
81 L 2E		Withdrawn
81 U A24		Withdrawn
67 L 26		Withdrawn
77 U 267		Withdrawn
62 U 3N		Withdrawn
77 L 46		Withdrawn
62 L 2E		Withdrawn
61 L 2D		Withdrawn
81 U 4H		Withdrawn
81 U 268		Withdrawn
59 U 3N		Withdrawn
61 L 4H		Withdrawn
77 L 35		Withdrawn
68 U 1H		Withdrawn
77 L 3P		Withdrawn
62 U 2P		Withdrawn
69 L 3D		Withdrawn
66 U 3P		Withdrawn
65 U 4N		Withdrawn
65 U 267		Withdrawn
69 U 134		Withdrawn
59 L 2C		Withdrawn
61 U 4N		Withdrawn
68 U 4N		Withdrawn
59 U 268		Withdrawn
69 L 4H		Withdrawn
69 L 35		Withdrawn
69 U 3M		Withdrawn
68 L 4H		Withdrawn
66 U A84		Withdrawn
61 L 2C		Withdrawn
68 U 133		Withdrawn
65 U 264		Withdrawn
65 U 263		Withdrawn
69 L 2E		Withdrawn
61 L 35		Withdrawn
65 U 268		Withdrawn
61 U 1H		Withdrawn
77 L 1N		Withdrawn
77 U 2D		Withdrawn
65 U A24		Withdrawn
77 U 133		Withdrawn
62 L 35		Withdrawn
62 L 3N		Withdrawn
65 U 135		Withdrawn
68 L 2E		Withdrawn
66 U 2N		Withdrawn
69 L 1H		Withdrawn
65 U 133		Withdrawn
59 L 26		Withdrawn
68 U 134		Withdrawn
68 U 264		Withdrawn
77 U 4M		Withdrawn
66 U 135		Withdrawn
68 U 3M		Withdrawn
68 U 267		Withdrawn
81 U 2N		Withdrawn
81 U 2P		Withdrawn
69 L 26		Withdrawn
67 L 2N		Withdrawn
69 L 2P		Withdrawn
77 U A23		Withdrawn
77 U 134		Withdrawn
66 L 46		Withdrawn
61 U 4M		Withdrawn
62 U 2N		Withdrawn
66 U 2P		Withdrawn
67 L 2P		Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Resin Teeth DCL PE	Ivoclar Vivadent Aktiengesellschaft	8,657
Primodent	Polident d.o.o.	3,814
Resin Teeth S PE S DCL	Ivoclar Vivadent Aktiengesellschaft	2,870
Vitapan	Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft	2,480
Myerson Special	The Myerson Company Limited	2,386
Kenson	The Myerson Company Limited	2,365
Candulor TCR	Candulor, AG	1,944
Vita Physiodens	Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft	1,788
Portrait® IPN® Anteriors	Dentsply LLC	1,674
Enigma Denture Teeth – Pairs	Davis Schottlander & Davis, Ltd.	1,632
Ivostar Gnathostar	Ivoclar Vivadent Aktiengesellschaft	1,501
REF-Line	Polident d.o.o.	1,458

Showing 12 of 9,979. All products under Denture, Plastic, Teeth

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K920684	1992-12-23
K831214	1983-05-09
K792245	1980-01-04
K780217	1978-03-15

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.

Biotone® Plastic Anteriors