Primary Device ID | E29951279 |
NIH Device Record Key | 1aed0005-97b7-491a-96ec-aeda387eeb93 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | maximat plus autoclavable spools |
Version Model Number | 5127 |
Company DUNS | 481461598 |
Company Name | Polydentia SA |
Device Count | 5 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch | |
Phone | +41919462948 |
info@polydentia.ch |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E29951270 [Primary] |
HIBCC | E29951279 [Unit of Use] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
[E29951279]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-13 |
Device Publish Date | 2022-07-05 |
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E29975010 - 3wedge | 2025-05-29 wood wedges, Assorted, 100 pcs. |
E29975029 - 3wedge | 2025-05-29 wood wedges, Small, 500 pcs |
E29975039 - 3wedge | 2025-05-29 wood wedges, Skinny, 500 pcs |
E29975049 - 3wedge | 2025-05-29 wood wedges, Large,500 pcs |
E29975059 - 3wedge | 2025-05-29 wood wedges, Jumbo, 500 pcs |
E29969139 - Unica Proximal | 2025-05-07 anterior matrices |
E29969149 - Unica Proximal | 2025-05-07 anterior matrices |