Singapore HSA registration DE0501375
GC Initial IQ Lustre Paste NF
Singapore·CLASS B·GC Europe N.V.·Registered March 14, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0501375
- Registration Date
- March 14, 2018
- Change Notification Approval Date
- October 01, 2018
- Retention Due Date
- March 13, 2026
Product description
The Initial IQ Lustre Pastes NF can be used in a wide CTE – Range (6.9-13.3) for the complete Initial line from GC. It is an alternative for conventional staining and glazing, as well as for the colour, brightness, grey value and surface texture corrections of all ceramic crowns and bridges. The Initial IQ Lustre Pastes NF Gum Shades is an alternative for conventional staining and glazing of the gingival areas. The device is intended to individualize the occlusal surface or gingival areas of ceramic crown and bridge work, to paint on white bands, decalcifications, hair lines and crack lines or to characterize artificial porcelain teeth.
Product Owner
- Name
- GC Europe N.V.
- Short Name
- GC Europe N.V.
- Address
- Interleuvenlaan 33, B-3001 Leuven, BELGIUM
Registrant
- Address
- 5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541
Importer
- Address
- 5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541
Model information
- Model Name(s)
- IQ/ Diluting Liquid 8ml IQ LP NF/ refresh liquid 8ml IQ/ LP NF L-N 4g IQ LP NF L-A 4g IQ LP NF L-B 4g IQ LP NF L-C 4g IQ LP NF L-D 4g IQ/ LP NF L-1 4g IQ/ LP NF L-2 4g IQ/ LP NF L-3 4g IQ/ LP NF L-4 4g IQ/ LP NF L-5 4g IQ/ LP NF L-6 4g IQ/ LP NF L-7 4g IQ/ LP NF L-8 4g IQ/ LP NF L-V 4g IQ LP NF G-23 4g IQ LP NF G-24 4g IQ LP NF G-34 4g IQ LP NF G-35 4g IQ LP NF G-36 4g LP-M1 3g (Stain Modifier for LP NF) LP-M2 3g (Stain Modifier for LP NF) LP-M3 3g (Stain Modifier for LP NF) LP-M4 3g (Stain Modifier for LP NF) IQ/ LP NF L-N 12g IQ/ LP NF L-9 4g IQ/ LP NF L-10 4g
- Model Identifier(s)
- 876220 876400 876401 876402 876403 876404 876405 876406 876407 876408 876409 876410 876411 876412 876413 876414 876415 876416 876417 876418 876419 876420 876421 876422 876423 876425 876426 876427
About this record
Access comprehensive regulatory information for GC Initial IQ Lustre Paste NF in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501375 and owned by GC Europe N.V.. The device was registered on March 14, 2018.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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