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Surgical Instrument
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CRT 05Model SURGICAL INSTRUMENT
Identity
- Trade Name
- JAW SINUS CURETTE Nº 5 EUDAMEDSURGICAL INSTRUMENT FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- CURETTE EUDAMEDJAW SINUS CURETTE 05 FDA UDI
- Model / Reference
- CRT 05 EUDAMEDFDA UDISURGICAL INSTRUMENT EUDAMED
- Description
- JAW SINUS CURETTE 05 FDA UDI
Identifiers
- Catalog Number
- CRT 05 FDA UDI
- Primary DI / UDI-DI
- 07899995219756 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000028K4 EUDAMED
- 510(k) Number
- K201688 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental osteotome
Surgical Instrument by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental osteotome.
- J & J INSTRUMENTS — J&J Instruments, LLC · Class I
- OSTEOTOME REPLACE - 5.0mm - CONCAVE O/S HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- devemed — devemed GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
- OSTEOTOME — KLS-Martin L.P. · Class I
- OSTEOTOME REPLACE - 6.0mm - RADIUS HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
Cleared under the same submission
K201688 also covers:
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- STERILIZATION BOX — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
- SURGICAL INSTRUMENT — S.I.N. - Sistema DE Implante Nacional S.A.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI deaeac7d-d013-4dbf-9980-6aadcb5b4b60 35 fields · synced Oct 6, 2026
- EUDAMED 869319fa-6a4d-4b78-8fb9-951c84e71548 61 fields · synced Jul 24, 2026