Who else makes this device?

Name: Piezomed SA-435 M Module plus
Brand: Piezomed SA-435 M Module plus

Piezomed SA-435 M Module Plus

Catalogue number 30406000, listed by W&H Dentalwerk Bürmoos GmbH, Austria, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Piezomed SA-435 M Module plus
Listed by	W&H Dentalwerk Bürmoos GmbH, Austria
FDA product code	DZI
Device type	Drill, Bone, Powered
Device class	Class 2
Regulation	21 CFR 872.4120
Record published	2022-10-19

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Piezomed SA-435 M Module plus
Catalogue number	Size	Status
30406000		In distribution

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K253655	2026-07-31

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.