Primary Device ID | E29963049 |
NIH Device Record Key | e14fb92c-9b31-4fda-896c-e99e5f7244af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | myTines small |
Version Model Number | 6304 |
Company DUNS | 481461598 |
Company Name | Polydentia SA |
Device Count | 12 |
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 | |
Phone | +41919462948 |
info@polydentia.ch |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E29963040 [Primary] |
HIBCC | E29963049 [Unit of Use] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
[E29963049]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-14 |
Device Publish Date | 2022-07-06 |
E29963079 - myTines GO | 2024-08-27 extremities for myClip 2.0 and myRing Forte |
E29958059 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm premolar |
E29958069 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm molar |
E29958359 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm premolar |
E29958369 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm molar |
E29958469 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm molar deep |
E29958569 - QuickmatFIT | 2024-02-06 anatomical sectional matrices 0.04mm molar deep |
E29910989 - QuickmatFLEX sectional matrices | 2023-08-31 0.03 mm / 6.4 mm 10 pcs. |