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EdgeEndo .06 Gutta Percha Points
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SGP4006-1Ref SGP3004-1Ref SGP5004-1Ref SGP4004-1Ref SGP2006-1Ref SGP2506-1Ref SGP2004-1Ref SGP4504-1Ref SGP4506-1Ref SGP1506-1Ref SGP5504-1Ref SGP5006-1Ref SGP3006-1
Identity
- Trade Name
- EdgeEndo .06 Gutta Percha Points EUDAMEDEdgeEndo .04 Gutta Percha Points EUDAMEDEdge .04 GP EUDAMEDFDA UDIEdgeEndo® Gutta Percha Points EUDAMEDEdge .06 GP FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- Gutta Percha Points EUDAMEDEdge 04 Gutta Percha Points 45.04 FDA UDIEdge 06 Gutta Percha Points 20.06 FDA UDIEdge 04 Gutta Percha Points 20.04 FDA UDIEdge 04 Gutta Percha Points 55.04 FDA UDIEdge 06 Gutta Percha Points 50.06 FDA UDIEdge 06 Gutta Percha Points 45.06 FDA UDIEdge 06 Gutta Percha Points 30.06 FDA UDIEdge 06 Gutta Percha Points 15.06 FDA UDIEdge 06 Gutta Percha Points 40.06 FDA UDIEdge 04 Gutta Percha Points 50.04 FDA UDIEdge 04 Gutta Percha Points 30.04 FDA UDIEdge 04 Gutta Percha Points 40.04 FDA UDIEdge 06 Gutta Percha Points 25.06 FDA UDI
- Model / Reference
- SGP4006-1 EUDAMEDFDA UDISGP3004-1 EUDAMEDFDA UDISGP5004-1 EUDAMEDFDA UDISGP4004-1 EUDAMEDFDA UDISGP2006-1 EUDAMEDFDA UDISGP2506-1 EUDAMEDFDA UDISGP2004-1 EUDAMEDFDA UDISGP4504-1 EUDAMEDFDA UDISGP4506-1 EUDAMEDFDA UDISGP1506-1 EUDAMEDFDA UDISGP5504-1 EUDAMEDFDA UDISGP5006-1 EUDAMEDFDA UDISGP3006-1 EUDAMEDFDA UDI
- Description
- Edge 04 Gutta Percha Points 45.04 FDA UDIEdge 06 Gutta Percha Points 20.06 FDA UDIEdge 04 Gutta Percha Points 20.04 FDA UDIEdge 04 Gutta Percha Points 55.04 FDA UDIEdge 06 Gutta Percha Points 50.06 FDA UDIEdge 06 Gutta Percha Points 45.06 FDA UDIEdge 06 Gutta Percha Points 30.06 FDA UDIEdge 06 Gutta Percha Points 15.06 FDA UDIEdge 06 Gutta Percha Points 40.06 FDA UDIEdge 04 Gutta Percha Points 50.04 FDA UDIEdge 04 Gutta Percha Points 30.04 FDA UDIEdge 04 Gutta Percha Points 40.04 FDA UDIEdge 06 Gutta Percha Points 25.06 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069209374 EUDAMEDFDA UDI08800069209275 EUDAMEDFDA UDI08800069209312 EUDAMEDFDA UDI08800069209299 EUDAMEDFDA UDI08800069209336 EUDAMEDFDA UDI08800069209343 EUDAMEDFDA UDI08800069209251 EUDAMEDFDA UDI08800069209305 EUDAMEDFDA UDI08800069209381 EUDAMEDFDA UDI08800069209329 EUDAMEDFDA UDI08800069213104 EUDAMEDFDA UDI08800069209398 EUDAMEDFDA UDI08800069209350 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926429GP2D EUDAMED
- Direct Marketing DI
- 08800069209374 EUDAMED08800069209275 EUDAMED08800069209312 EUDAMED08800069209299 EUDAMED08800069209336 EUDAMED08800069209343 EUDAMED08800069209251 EUDAMED08800069209305 EUDAMED08800069209381 EUDAMED08800069209329 EUDAMED08800069213104 EUDAMED08800069209398 EUDAMED08800069209350 EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Synthetic gutta-percha FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EdgeEndo .06 Gutta Percha Points by Sure Dent Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926429GP2D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sure Dent Corporation
- EUDAMED SRN
- KR-MF-000018662
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (39)
- EUDAMED 901379ae-3850-489d-92b3-8ba8fbd966a7 61 fields · synced Sep 18, 2026
- EUDAMED 9fe13457-25c7-4246-845f-6c26c2dca167 61 fields · synced May 17, 2026
- EUDAMED ad069b35-8a49-4298-bd74-77b0d02811dd 61 fields · synced May 17, 2026
- EUDAMED fbb0a5b6-8222-4bb6-84c5-4a4c5280539e 61 fields · synced May 17, 2026
- EUDAMED 232e1326-6c6b-48dd-86f3-17d28ee9a31e 61 fields · synced May 18, 2026
- EUDAMED 051cfe7e-6ffb-4832-80dd-90c8a7f1d4b5 61 fields · synced May 18, 2026
- EUDAMED 74e54534-308a-4fe7-a34e-95d7239d451e 61 fields · synced May 18, 2026
- EUDAMED e40923e2-1620-45c8-9003-e747ec528fcb 61 fields · synced May 18, 2026
- EUDAMED 3d40c4d3-769c-4be2-b540-129d42befbbe 61 fields · synced May 18, 2026
- EUDAMED 4f0b8e84-6ad6-44d8-9ac7-4e6235678f6b 61 fields · synced May 18, 2026
- EUDAMED 8b80f162-d1bf-41b7-b064-9db43cb1bbc8 61 fields · synced May 18, 2026
- EUDAMED a2ae6305-1eff-47b0-91b3-cf453894c48b 61 fields · synced May 19, 2026
- EUDAMED b6302e50-8268-447a-8d0b-ba50e9e79284 61 fields · synced May 19, 2026
- FDA UDI b1e247bc-4409-47f8-b1b7-98941a8d5711 34 fields · synced May 26, 2026
- FDA UDI 1a5c9e35-ba7d-4ea8-92f8-0fc78b194a6e 34 fields · synced May 30, 2026
- FDA UDI d1573de4-af42-42bd-a7df-e47d0e0a2b02 34 fields · synced May 30, 2026
- FDA UDI 4ee2cf07-31e2-4676-bcd1-e39e7310e9a8 33 fields · synced May 30, 2026
- FDA UDI d60445be-9eb0-4187-b889-3624db9eac5a 34 fields · synced May 30, 2026
- FDA UDI 7228e58f-6342-4db1-808f-2ef4904284aa 34 fields · synced May 30, 2026
- FDA UDI 9b494fc7-dc61-4036-8d34-ad2ea6e961f6 34 fields · synced May 30, 2026
- FDA UDI 864faf6c-c722-4468-aff8-914e9e88614e 34 fields · synced May 30, 2026
- FDA UDI eff5162c-3699-4ea4-a396-0e96df71c7a4 34 fields · synced May 30, 2026
- FDA UDI 7c23c0e0-c925-4535-ac14-f5c4dfe346e4 34 fields · synced May 30, 2026
- FDA UDI 2d26410a-2816-48d8-a5b3-f447e14a4333 34 fields · synced May 30, 2026
- FDA UDI b1fed900-e816-433b-bf55-d4b298cc08be 34 fields · synced May 30, 2026
- FDA UDI 05b816e8-0fae-4f4a-852e-01658c7d960e 34 fields · synced May 30, 2026
- EUDAMED 014c786e-8d51-49fd-9e42-e5e1c1456e5d 61 fields · synced Jul 9, 2026
- EUDAMED e3a77ab3-9380-41a5-8d27-445e168e0bc8 61 fields · synced Jul 10, 2026
- EUDAMED df139f36-2436-4593-827f-277399917860 61 fields · synced Jul 13, 2026
- EUDAMED cf8d12f1-5daf-4dcc-95b7-9cc95d1a96fd 61 fields · synced Jul 13, 2026
- EUDAMED 27140df5-b225-4200-a823-3c535dcb37f1 61 fields · synced Jul 13, 2026
- EUDAMED 5a0f35e9-8617-4bf6-a6e6-a1725dcd0beb 61 fields · synced Jul 15, 2026
- EUDAMED aae936bf-0a2f-41ba-a493-85856c0a32cc 61 fields · synced Jul 16, 2026
- EUDAMED 467a93fb-f7b6-4e06-9ad2-a0d5427d06c1 61 fields · synced Jul 21, 2026
- EUDAMED cf72867f-346d-4854-846d-3fb326b6476f 61 fields · synced Jul 22, 2026
- EUDAMED 95aa91fb-e506-4123-a6a4-9555cbb35cba 61 fields · synced Jul 29, 2026
- EUDAMED b4eb3512-b924-4b15-9231-17826684cec5 61 fields · synced Jul 31, 2026
- EUDAMED 10f09b88-67cd-4ce2-820a-36f01422c939 61 fields · synced Aug 4, 2026
- EUDAMED 3297002d-47f5-4114-b2ba-09ef488986a7 61 fields · synced Sep 18, 2026