Primary Device ID | J021305000000 |
NIH Device Record Key | 79ad8a04-c77e-49fb-b9be-4128694c79c8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Piezomed Pro M-PM100 |
Version Model Number | 30500000 |
Company DUNS | 300238441 |
Company Name | W & H Dentalwerk Bürmoos GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J021305000000 [Direct Marking] |
HIBCC | J021305000001 [Primary] |
ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-16 |
Device Publish Date | 2025-07-08 |
J021305000000 - Piezomed Pro M-PM100 | 2025-07-16Piezomed Pro Module |
J021305000000 - Piezomed Pro M-PM100 | 2025-07-16 Piezomed Pro Module |
J021305010000 - Piezomed Pro M-PH350 | 2025-07-16 Piezomed Pro Handpiece |
J021305020001 - Piezomed Pro Accessory | 2025-07-16 Instrument MP1 |
J021305020011 - Piezomed Pro Accessory | 2025-07-16 Instrument MR1 |
J021305020021 - Piezomed Pro Accessory | 2025-07-16 Instrument MR2 |
J021305020031 - Piezomed Pro Accessory | 2025-07-16 Instrument MR3 |
J021305020041 - Piezomed Pro Accessory | 2025-07-16 Instrument MR4 |
J021305020051 - Piezomed Pro Accessory | 2025-07-16 Instrument MR5 |