Who else makes this device?

Name: Bioblend® Porcelain Anteriors
Brand: Bioblend® Porcelain Anteriors

Bioblend® Porcelain Anteriors · Teeth, Porcelain → Dental

3manufacturers in China registered for this device type

696catalogue numbers in this listing

5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (1), Sichuan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELL
Manufacturer	City	Province	Registered as	Device types
Shenzhen Jiahong Dental Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	7
Xiao Fei Dental Manufacture (Chengdu) Co., Ltd.	Chengdu	Sichuan	Remanufacturer	5
Hangzhou Thales Medtech Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	3

Record

Regulatory record for Bioblend® Porcelain Anteriors
Listed by	Dentsply LLC, United States
FDA product code	ELL
Device type	Teeth, Porcelain
Device class	Class 2
Regulation	21 CFR 872.3920
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-10-10
Record revised	2022-05-24 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number
Distribution end date	2022-05-23

Catalogue Numbers

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109 U 45F		Withdrawn
104 U 55D		Withdrawn
112 U 21C		Withdrawn
113 L C		Withdrawn
108 U 21X		Withdrawn
114 U 22H		Withdrawn
108 U 42D		Withdrawn
113 L U		Withdrawn
118 U 62G		Withdrawn
106 U 32B		Withdrawn
102 U 42D		Withdrawn
106 U 11H		Withdrawn
104 U 45H		Withdrawn
110 L K		Withdrawn
104 U 22H		Withdrawn
106 L H		Withdrawn
108 U 62G		Withdrawn
106 U 42D		Withdrawn
108 U 12E		Withdrawn
112 U 43D		Withdrawn
110 U 22G		Withdrawn
106 U 22H		Withdrawn
113 L P		Withdrawn
109 U 55D		Withdrawn
102 L W		Withdrawn
110 U 25G		Withdrawn
102 U 45H		Withdrawn
104 U 42F		Withdrawn
118 U 12E		Withdrawn
118 U 43D		Withdrawn
108 U 11G		Withdrawn
102 U 45F		Withdrawn
112 L H		Withdrawn
108 L K1		Withdrawn
110 L F		Withdrawn
108 U 25G		Withdrawn
110 U 12E		Withdrawn
106 L D		Withdrawn
106 L W		Withdrawn
110 L K1		Withdrawn
109 U 42G		Withdrawn
109 U 44E		Withdrawn
114 L S		Withdrawn
100 U 21H		Withdrawn
108 L M		Withdrawn
104 U 21E		Withdrawn
113 U 12E		Withdrawn
110 U 11H		Withdrawn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

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bioform® VF Porcelain Anteriors	Dentsply LLC	1,050
New Hue® VF Porcelain Anteriors	Dentsply LLC	240
Physioset CT	Candulor, AG	236
Bioform® VF 33 Deg. Porcelain Posteriors	Dentsply LLC	182
Bioform® VF 20 Deg. Porcelain Posteriors	Dentsply LLC	144
NobelProcera®	Nobel Biocare AB	112
Bioform® VF Rational Porcelain Posts	Dentsply LLC	84
Bonartic CT	Candulor, AG	80
Condyloform CT	Candulor, AG	71
Bioform® VF Functional Porcelain Posts	Dentsply LLC	56
Duo:PCH®	DEN-MAT Holdings, LLC	29
Vivid ZirDisc Wieland System	Pearson Dental Supplies, Inc.	27

Showing 12 of 25. All products under Teeth, Porcelain

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K880774	1988-05-18
K864724	1987-02-17
K860608	1986-03-26
K823744	1982-12-28
K771179	1977-07-15

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® Porcelain Anteriors