Identity
- Trade Name
- HEXAGONAL RETENTION SCREW 4 FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- HEXAGONAL RETENTION SCREW 4 FDA UDI
- Model / Reference
- PRH 40 PACK4 FDA UDI
- Description
- HEXAGONAL RETENTION SCREW 4 FDA UDI
Identifiers
- Catalog Number
- PRH 40 PACK4 FDA UDI
- Primary DI / UDI-DI
- 07899995272140 FDA UDI
- 510(k) Number
- K231127 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
Hexagonal Retention Screw 4 by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
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- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K231127 also covers:
- ABUTMENT MINI ANGLED MORSE TAPER Ø4, 8X2X 45° INDEX — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUTMENT MINI ANGLED MORSE TAPER Ø4, 8X3X 45° INDEX — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X30, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X32, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X35, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X37, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X40, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X42, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X45, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X47, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X50, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X52, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (1)
- FDA UDI 88c980b2-bfd3-413e-a875-fd2ecb2946f7 35 fields · synced May 30, 2026