Documentation

All our products hold a certification of conformity. Here you can find all the documentation, catalogued by type.

Quality system certificates

Lancer MDSAP Certificate
Lancer CE Certificate 02013
Lancer ISO 13485:2016 Certificate FM 78272
Kristal S.r.l. CE Certificate 0476
Kristal S.r.l. ISO 13485-2016 Certificate 11136-M

Declaration of Conformity

Class I Blaze Dental Curing Light
Class I Mouth Mirrors
Class I Orthodontic Hand Instruments
Class I Orthodontic Head Gear
Class I Orthodontic Patient Home Care Kit
Class I Relief Wax
Class I Spool Dispensers
Class I Surgical Kit - SASKIT - Storm Mini Screw
Class I Typodonts
Class IIa Ceramic Orthodontic Brackets
Class IIa Crimpable Ball Hooks
Class IIa Face Bows
Class IIa Metal Orthodontic Bands (Stainless Steel)
Class IIa Metal Orthodontic Brackets (Stainless Steel)
Class IIa Orthodontic Adhesive Products
Class IIa Orthodontic Buccal Tubes
Class IIa Orthodontic Elastomerics
Class IIa Orthodontic Lingual Attachments
Class IIa Orthodontic Protraction Face Mask
Class IIa Orthodontic Springs
Class IIa Orthodontic Wire
Class IIa Rapid Palatal Expander
Class IIa Retainer Cases
Class IIa Straight Forward Philosophy® SFP Kit
Class IIb Orthodontic Anchoring Screw - Storm Mini Screw
Palatal Expander_Declaration of conformity
Tems with no MSDS requirements
Kristal Clear_Declaration of conformity
TAD_Declaration of conformity