Who else makes this device?

Name: Bioblend® IPN® Anteriors
Brand: Bioblend® IPN® Anteriors

Bioblend® IPN® Anteriors · Denture, Plastic, Teeth → Dental

26manufacturers in China registered for this device type

696catalogue 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 Bioblend® IPN® 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
Record published	2016-10-10
Record revised	2023-12-13 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2022-06-01

Catalogue Numbers

Catalogue numbers for Bioblend® IPN® Anteriors
Catalogue number	Size	Status
110 U 22E		Withdrawn
113 L C		Withdrawn
100 U 45F		Withdrawn
116 L S		Withdrawn
116 U 32G		Withdrawn
116 U 11G		Withdrawn
109 L D		Withdrawn
118 U 42G		Withdrawn
100 U 11G		Withdrawn
109 L Z		Withdrawn
113 U 11D		Withdrawn
113 U 42C		Withdrawn
113 L S		Withdrawn
118 U 21C		Withdrawn
114 L R		Withdrawn
114 L P		Withdrawn
110 U 22G		Withdrawn
104 U 32B		Withdrawn
102 L W		Withdrawn
108 U A84		Withdrawn
106 U 62D		Withdrawn
114 U 32B		Withdrawn
109 U 52C		Withdrawn
104 U 21D		Withdrawn
118 L C		Withdrawn
113 U 62G		Withdrawn
109 L M		Withdrawn
100 L N		Withdrawn
102 L C		Withdrawn
110 L D		Withdrawn
112 U 43D		Withdrawn
108 L Z		Withdrawn
114 U 45F		Withdrawn
114 L H		Withdrawn
112 U 55D		Withdrawn
100 U 75E		Withdrawn
112 U 25G		Withdrawn
116 U 12G		Withdrawn
114 U 42G		Withdrawn
100 U 21G		Withdrawn
108 L W		Withdrawn
112 U 32E		Withdrawn
113 U 13E		Withdrawn
102 U 42F		Withdrawn
110 U 44E		Withdrawn
110 L P		Withdrawn
118 U A84		Withdrawn
114 L K		Withdrawn
114 L K1		Withdrawn
100 L S		Withdrawn
104 U 21C		Withdrawn
102 U 65G		Withdrawn
109 U 32E		Withdrawn
112 U 21D		Withdrawn
100 U 55F		Withdrawn
114 U 21C		Withdrawn
106 U 22G		Withdrawn
100 U 32G		Withdrawn
108 U 21C		Withdrawn
116 U 43D		Withdrawn
116 L E		Withdrawn
113 U 22E		Withdrawn
113 L W		Withdrawn
113 U 45F		Withdrawn
114 U 42H		Withdrawn
118 U 52C		Withdrawn
108 U 32E		Withdrawn
112 U 11H		Withdrawn
116 U 22G		Withdrawn
110 L R		Withdrawn
106 U 32B		Withdrawn
100 U 62D		Withdrawn
104 U 12E		Withdrawn
113 L H		Withdrawn
109 L H		Withdrawn
118 U 32B		Withdrawn
112 U 42G		Withdrawn
113 L K		Withdrawn
102 U 11D		Withdrawn
118 U 45F		Withdrawn
109 U 21X		Withdrawn
118 U 43D		Withdrawn
100 U 21C		Withdrawn
100 U 44E		Withdrawn
113 L Z		Withdrawn
108 U 45F		Withdrawn
110 U 75E		Withdrawn
112 U 24F		Withdrawn
112 U 32G		Withdrawn
108 U 32B		Withdrawn
100 U 45H		Withdrawn
102 L N		Withdrawn
106 U 12G		Withdrawn
112 U 44E		Withdrawn
110 L Z		Withdrawn
104 U 21H		Withdrawn
106 U 54F		Withdrawn
113 U 75E		Withdrawn
108 U 21H		Withdrawn
116 U 24F		Withdrawn
112 U 12E		Withdrawn
110 L W		Withdrawn
113 U 21X		Withdrawn
106 U 21D		Withdrawn
100 U 12G		Withdrawn
118 U 44E		Withdrawn
114 U 45H		Withdrawn
108 U 62G		Withdrawn
116 L M		Withdrawn
100 U 42H		Withdrawn
100 U 42D		Withdrawn
104 U 13E		Withdrawn
118 U 54F		Withdrawn
109 U 21G		Withdrawn
100 L K		Withdrawn
106 L H		Withdrawn
116 U 22H		Withdrawn
114 U 75E		Withdrawn
109 U 45H		Withdrawn
113 U 25G		Withdrawn
112 L F		Withdrawn
112 U 62G		Withdrawn
116 U 21E		Withdrawn
110 U 62G		Withdrawn
104 L H		Withdrawn
118 U 24F		Withdrawn
109 U 43D		Withdrawn
113 U 44E		Withdrawn
108 U 54F		Withdrawn
102 U 11G		Withdrawn
102 U 75E		Withdrawn
104 U 45F		Withdrawn
118 U 22H		Withdrawn
109 U 21J		Withdrawn
109 L S		Withdrawn
100 L O		Withdrawn
104 U A84		Withdrawn
106 U 52C		Withdrawn
108 U 21D		Withdrawn
116 U 62G		Withdrawn
100 U 42G		Withdrawn
102 L K1		Withdrawn
104 L U		Withdrawn
109 U 11G		Withdrawn
102 U 54F		Withdrawn
116 L P		Withdrawn
100 L H		Withdrawn
104 U 42D		Withdrawn
106 U 43D		Withdrawn
104 U 54F		Withdrawn
112 L O		Withdrawn
110 U 12E		Withdrawn
109 U 42C		Withdrawn
100 L R		Withdrawn
102 U 21G		Withdrawn
102 U 45F		Withdrawn
109 U 42H		Withdrawn
108 U 22C		Withdrawn
106 L K1		Withdrawn
102 L E		Withdrawn
116 U 55D		Withdrawn
112 L R		Withdrawn
104 U 62D		Withdrawn
116 U 21J		Withdrawn
118 U 13E		Withdrawn
106 U 24F		Withdrawn
116 L H		Withdrawn
106 U 45H		Withdrawn
116 L O		Withdrawn
102 L O		Withdrawn
118 U 11D		Withdrawn
112 U 42C		Withdrawn
114 U 24F		Withdrawn
104 U 24F		Withdrawn
113 U 21J		Withdrawn
114 U 43F		Withdrawn
116 U A84		Withdrawn
114 U 62D		Withdrawn
109 U 12E		Withdrawn
110 U 22C		Withdrawn
118 U 32G		Withdrawn
106 L O		Withdrawn
106 U 22E		Withdrawn
112 L W		Withdrawn
102 U 32B		Withdrawn
116 U 45H		Withdrawn
110 U 21E		Withdrawn
118 L K1		Withdrawn
100 U 22G		Withdrawn
118 U 43F		Withdrawn
106 U 55D		Withdrawn
102 U 13E		Withdrawn
110 U 31F		Withdrawn
118 L S		Withdrawn
108 L C		Withdrawn
116 L D		Withdrawn
114 U A84		Withdrawn
112 L N		Withdrawn
106 L M		Withdrawn
112 L D		Withdrawn
106 U 43F		Withdrawn
112 U 22C		Withdrawn
100 U 43F		Withdrawn
106 U 42H		Withdrawn
113 U 55F		Withdrawn
113 U 21E		Withdrawn
108 U 11G		Withdrawn
110 U 11D		Withdrawn
102 U 55F		Withdrawn
110 L K1		Withdrawn
100 U 21E		Withdrawn
118 U 55F		Withdrawn
106 U 62G		Withdrawn
118 L Z		Withdrawn
102 U 25G		Withdrawn
109 U 42D		Withdrawn
113 L P		Withdrawn
100 L W		Withdrawn
116 L Z		Withdrawn
113 L F		Withdrawn
110 U 55D		Withdrawn
109 U 55D		Withdrawn
110 U 43D		Withdrawn
100 U 21H		Withdrawn
100 U 31F		Withdrawn
110 U 11G		Withdrawn
116 U 21C		Withdrawn
106 U 32E		Withdrawn
113 U 21D		Withdrawn
113 U 22H		Withdrawn
116 U 55F		Withdrawn
118 U 25G		Withdrawn
114 U 21X		Withdrawn
106 L R		Withdrawn
100 U 32E		Withdrawn
112 L H		Withdrawn
108 L H		Withdrawn
116 U 42H		Withdrawn
118 U 22E		Withdrawn
108 L E		Withdrawn
113 U 65G		Withdrawn
106 L C		Withdrawn
108 U 42F		Withdrawn
118 U 22G		Withdrawn
114 U 12G		Withdrawn
112 U 21G		Withdrawn
106 U 42G		Withdrawn
114 U 32E		Withdrawn
114 U 22G		Withdrawn
118 U 65G		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.

Bioblend® IPN® Anteriors