← Back to catalogue

Bonefit Implant System Accessories & Instruments

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
NN Closure screw set, consisting of: 2 NN Closure screws, height 1.8mm, internal hexagon, titanium and 1 Hexagonal screwdriver, FDA UDI
Model / Reference
1 FDA UDI
Description
NN Closure screw set, consisting of: 2 NN Closure screws, height 1.8mm, internal hexagon, titanium and 1 Hexagonal screwdriver, FDA UDI

Identifiers

Catalog Number
040.395 FDA UDI
Primary DI / UDI-DI
07630031717382 FDA UDI
510(k) Number
K894844 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Bonefit Implant System Accessories & Instruments by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K894844 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Institut Straumann SA

Sources (1)

  • FDA UDI 024d0fe8-dc85-4272-906c-0f60dd73cc4a 38 fields · synced May 31, 2026