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Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper
EUDAMEDClass IIa (EU MDR)
Ref SB-PGVTF2Ref SB-PG6TP030Ref SB-PG6TP040Ref SB-PG6TP045Ref SB-PGTCO020Ref SB-PG4TP040Ref SB-PG4TP045Ref SB-PGTCO040Ref SB-PGTCO035Ref SB-PG6TP035Ref SB-PGTCOASGRef SB-PG6TPASSRef SB-PGTCOASPRef SB-PGTCO030Ref SB-PG6TP025Ref SB-PGVTF1Ref SB-PG6TP020Ref SB-PGTCO025Ref SB-PG4TP030Ref SB-PGVTASSRef SB-PGTCO015
Identity
- Trade Name
- Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper EUDAMED
- Device Name
- Gutta Percha Points EUDAMED
- Model / Reference
- SB-PGVTF2 EUDAMEDSB-PG6TP030 EUDAMEDSB-PG6TP040 EUDAMEDSB-PG6TP045 EUDAMEDSB-PGTCO020 EUDAMEDSB-PG4TP040 EUDAMEDSB-PG4TP045 EUDAMEDSB-PGTCO040 EUDAMEDSB-PGTCO035 EUDAMEDSB-PG6TP035 EUDAMEDSB-PGTCOASG EUDAMEDSB-PG6TPASS EUDAMEDSB-PGTCOASP EUDAMEDSB-PGTCO030 EUDAMEDSB-PG6TP025 EUDAMEDSB-PGVTF1 EUDAMEDSB-PG6TP020 EUDAMEDSB-PGTCO025 EUDAMEDSB-PG4TP030 EUDAMEDSB-PGVTASS EUDAMEDSB-PGTCO015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069210080 EUDAMED08800069210028 EUDAMED08800069210042 EUDAMED08800069210059 EUDAMED08800069209862 EUDAMED08800069209978 EUDAMED08800069209985 EUDAMED08800069209909 EUDAMED08800069209893 EUDAMED08800069210035 EUDAMED08800069209923 EUDAMED08800069210066 EUDAMED08800069209916 EUDAMED08800069209886 EUDAMED08800069210011 EUDAMED08800069210073 EUDAMED08800069210004 EUDAMED08800069209879 EUDAMED08800069209954 EUDAMED08800069210103 EUDAMED08800069209855 EUDAMED
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069210080 EUDAMED08800069210028 EUDAMED08800069210042 EUDAMED08800069210059 EUDAMED08800069209862 EUDAMED08800069209978 EUDAMED08800069209985 EUDAMED08800069209909 EUDAMED08800069209893 EUDAMED08800069210035 EUDAMED08800069209923 EUDAMED08800069210066 EUDAMED08800069209916 EUDAMED08800069209886 EUDAMED08800069210011 EUDAMED08800069210073 EUDAMED08800069210004 EUDAMED08800069209879 EUDAMED08800069209954 EUDAMED08800069210103 EUDAMED08800069209855 EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Steriblue Gutta Points, Color-End-Gutta, ISO-Taper, Vario-Taper by Sure Dent Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926429GP2D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (21)
- EUDAMED d62d287e-17af-4ee9-a941-6ba708875e29 61 fields · synced Oct 6, 2026
- EUDAMED cb78396e-8593-4468-8b57-d95c2a004ef1 61 fields · synced May 16, 2026
- EUDAMED 997bc33d-d00b-4332-b0de-c64bcbc07d8d 61 fields · synced May 17, 2026
- EUDAMED 2fb6f24c-3975-4017-92c8-5661c5a68bb5 61 fields · synced May 17, 2026
- EUDAMED 5cc7d78b-61de-4636-bc62-b8ba76ebc3c1 61 fields · synced May 17, 2026
- EUDAMED d4498bc2-8330-4383-af83-14d00a36a1a5 61 fields · synced May 17, 2026
- EUDAMED 624a3a22-3403-48ec-98e8-de7fe6e9dcc6 61 fields · synced May 17, 2026
- EUDAMED 1f0b41e2-4b0a-4fae-aad1-45aa8093e6ea 61 fields · synced May 17, 2026
- EUDAMED 90223622-7342-49ee-be41-76eadc8e8b9c 61 fields · synced May 17, 2026
- EUDAMED d2012f2f-85a3-4864-90fd-89e74f0884eb 61 fields · synced May 17, 2026
- EUDAMED 9554b351-81cf-4de8-83f5-72f204f28a07 61 fields · synced May 17, 2026
- EUDAMED 8f2e6586-bd59-4a94-abe4-cd33da6c99b0 61 fields · synced May 17, 2026
- EUDAMED 05a7ae03-36f6-4dd9-b881-9cc01d05de4e 61 fields · synced May 18, 2026
- EUDAMED 7a176dff-8420-48b8-8163-6c434e02d759 61 fields · synced May 18, 2026
- EUDAMED 4ea97ea4-f0ac-4331-bed1-5e925aa0f843 61 fields · synced May 18, 2026
- EUDAMED 57fc6dff-bdfb-45ca-8ffd-63543d5b8934 61 fields · synced May 18, 2026
- EUDAMED 97c99b4e-a056-4c91-9edb-39efa91fb652 61 fields · synced May 18, 2026
- EUDAMED 92e567b2-e483-4103-9f44-8e9826e93918 61 fields · synced May 18, 2026
- EUDAMED 9a64553a-af65-4180-a53c-78c71dc8105f 61 fields · synced May 19, 2026
- EUDAMED 6c44e4a5-f109-4b0f-afb4-fe75cb4c2bda 61 fields · synced May 19, 2026
- EUDAMED 9401114e-6f02-4be2-8ebd-5df15058c109 61 fields · synced May 19, 2026