Identity
- Trade Name
- Stern EX RP 4.0mm Bone Tap FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- The Stern EX 4.0mm Bone Tap. A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes. FDA UDI
- Model / Reference
- 905108 FDA UDI
- Description
- The Stern EX 4.0mm Bone Tap. A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549114472 FDA UDI
- 510(k) Number
- K023580 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Stern EX RP 4.0mm Bone Tap by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K023580 also covers:
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
- Sterngold Dental LLC
Sources (1)
- FDA UDI 1f8a9194-c166-49a8-9fcc-7e9c28c3ba39 36 fields · synced May 31, 2026