Medical device licence · 91597 · Class 2
ALPEN DIAMOND INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 3, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91597
- Licence holder
- ColteneLangenau, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 3, 2013
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACORN
- AMALGAM REMOVER
- BEVELED CYLINDER
- DEPTH MARKER
- END CUTTING
- ESTHETIC FINISHING
- FLAME
- FLAT END CYLINDER
- FLAT END TAPER
- FOOTBALL
- INTERPROXIMAL
- INVERTED CONE
- INVERTED CONE COLLAR
- INVERTED CONE/LONG
- KS SHAPE
- LONG FLAT END TAPER
- MODIFIED END CYLINDER
- MODIFIED END TAPER
- OCCLUSAL BARREL
- PEAR
- PEAR/LONG
- POINTED BARREL
- POINTED TAPER
- PONTED FOOTBALL
- ROUND
- ROUND END CYLINDER
- ROUND END TAPER
- ROUND END TAPER/LARGE
- ROUND WHEEL
- STRIATED CYLINDER
- WHEEL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “alpen”. A notice may cover another product or only some lots: read it to see what it covers.
- Alpen Clinic 100 Carbide & Alpen SteriX (2020-10-16)November 6, 2020 · Medical devices · Medical devices · Type II
- Alpen Carbide 702 Cross Cut Tapered Fissure FG lOpk (Carbide burs) (2018-04-18)November 30, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.