Chisel, Osteotome, Surgical

Which Manufacturers in China Make This?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Shandong, and 1 other province. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

B.Braun Medical (Suzhou) Co,.Ltd Jiangsu, contract manufacturer
Pengbo (Shenzhen) Medical Technology Co., Ltd. Guangdong
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

How Is EMM Classified?

Chisel, Osteotome, Surgical is FDA product code EMM, Class 1, 21 CFR 872.4565.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Chisel, Osteotome, Surgical

Osteotome, 6MM

Catalogue number 95-6006, listed by Biopro, Inc., United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome-Chisel 3.0mm

Catalogue number 20-0233, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Anthogyr Osteo Safe

Catalogue number 6920OSTS, listed by Etablissements Anthogyr, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

OSTEOTOME-7″-4mm-STRAIGHT

Catalogue number 20-0149, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Chisel 1/2″ Thin ON CH 6mm

Catalogue number 20-0236-7, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotomes- 4mm OSC 120mm L

Catalogue number 20-0130OSC, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome, Straight Silver Nasal Guarded, 7″

Catalogue number 20-0240-1, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

TSplitter, 10MM X 310MM

Catalogue number 95-7541, listed by Biopro, Inc., United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Gouge 7mm CH S/E

Catalogue number 10-5337CH, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome-Chisel 5.0mm

Catalogue number 20-0235, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Mini-Lexer, Osteotome 8mm, Straight

Catalogue number 1675-08, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

G Source

Hibbs Osteotome 9" str 1/2" [13mm]

Chisel, Osteotome, Surgical

Bone Chisel 7mm HD Curved

Catalogue number 10-5307HDC, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

OSTEOTOME-7″-8mm-STRAIGHT 12-9-6-3MM

Catalogue number 20-0151, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

OSTEOTOMES-4mm OS 120mm L

Catalogue number 20-0130OS, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome, Curved Lambotte, 25MM

Catalogue number 3365125, listed by Biopro, Inc., United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome, 18MM

Catalogue number 95-1818, listed by Biopro, Inc., United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Obwegeser Splitting Osteo 16MM

Catalogue number 20-0749, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bsso Splitting Osteotome 2/6mm

Catalogue number 20-0728-1, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

T-Spreader #2

Catalogue number 20-0272, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 4mm Short CH

Catalogue number 10-5304-1CH, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 7mm HD BI Bevel

Catalogue number 10-5307HDB, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Tatum Channel Former D4 10.0mm

Tatum D4 10.0 D Shaped Channel former used for creating an osteotomy for a dental implant

Chisel, Osteotome, Surgical

Cullum Bone Spreader 2.2mm

Catalogue number 20-0280-22, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 3mm HD Curved

Catalogue number 10-5303HDC, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Gouge 3mm Bayonet CH S/E

Catalogue number 10-5333BCH, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel Gardner Reverse

Catalogue number 10-5310HD, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Gouge 3mm CH S/E

Catalogue number 10-5333CH, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Anthogyr Universal Surgical Instrument

Universal Surgical Instrument

Chisel, Osteotome, Surgical

Osteotome, 12MM

Catalogue number 95-1212, listed by Biopro, Inc., United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

OSTEOTOME-7″-2mm-STRONG Curve

Catalogue number 20-0148-2, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome, 7″, 6mm, Offset, Hexed Handle

Catalogue number 20-0150-3H, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Interdental Osteotomy Osseo 4mm Flat With BI-Bevel Sharp END

Catalogue number 20-0725-2B, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Obwegeser Osteotome Splitting 15MM

Catalogue number 20-0615, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 2.5MM, 6″ S/E

Catalogue number 10-5382-01, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Salvin Cottle Curved Chisel – 4mm Wide

Catalogue number COTTLE-4, listed by Salvin Dental Specialties, LLC, United States, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 2mm HD BI Bevel

Catalogue number 10-5302HDB, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Bone Chisel 4mm CH

Catalogue number 10-5304CH, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

OSTEOTOME-7″-4mm-SLIGHT Curve 12-9-6-3mm

Catalogue number 20-0149-1, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Symmetry Tessier

Symmetry® Osteotome, Tessier Nasal, Curved, 7 mm, 6 1/4 in

Chisel, Osteotome, Surgical

Bone Chisel 7mm CH Curved

Catalogue number 10-5307CHC, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Symmetry Epker

Symmetry® Osteotome, Epker, Straight, 6 mm x 1.2 mm, 7 in, 177 mm

Chisel, Osteotome, Surgical

Osteotome, 7″, 4mm Slight Curve Markings 12-9-6-3mm, Hexed Handle

Catalogue number 20-0149-1H, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Chisel, Osteotome, Surgical

Osteotome-Nasal Ball-END-V SHA

Catalogue number 20-0440-1, listed by W.H. Holden, Inc., under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer