RP Pilot Drill Drill, 2.0 – 3.0mm

A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental…

Registry build 21.09.26

A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into. This device is used for preparation of the bony receptor site involves the sequential use of drills and drilling components. Sterngold-ImplaMed® offers three drilling configurations; Externally Cooled Twist Drills, Internally Cooled Spade Drills, and Internally Cooled “Three Spade” Drills. All three styles are precision machined from high strength stainless steel and feature convenient depth markings and standard latch-type connectors.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangxi (1), Guangdong (1).

Chinese manufacturers registered for FDA product code DZI
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Guangdong Jinme Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 13

Record

Regulatory record for RP Pilot Drill Drill, 2.0 – 3.0mm
Listed by Sterngold Dental LLC, United States
FDA product code DZI
Device type Drill, Bone, Powered
Device class Class 2
Regulation 21 CFR 872.4120
Establishment Repacker / relabeller, Manufacturer
510(k) K902158
Record published 2017-07-05
Record revised 2023-10-09 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2023-10-06

Catalogue Numbers

Catalogue numbers for RP Pilot Drill Drill, 2.0 – 3.0mm
Catalogue number Size Status
905173 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Drill, Bone, Powered Synthes Gmbh 150
Acteon Satelec 87
Neoss Implant System Neoss AB 74
Mectron Mectron SPA 48
OneDrill Surgical Drill Osseofuse International Inc. 48
Silfradent srl Silfradent SRL 45
MatrixMANDIBLE Synthes Gmbh 31
DIRECTguide™ Step Drill Implant Direct Sybron Manufacturing LLC 31
DIRECTguide™ Guided Step Drill Implant Direct Sybron Manufacturing LLC 30
Woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 28
VarioSurg Nakanishi Inc. 22
Nobel Biocare® Nobel Biocare AB 20

Showing 12 of 265. All products under Drill, Bone, Powered

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.

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