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PUR NP Implant 5.0 x 10mm, Ti

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
PUR NP Implant 5.0 x 10mm, Ti FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR Implant System can be used in dental implant applications, for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary. FDA UDI
Model / Reference
901366 FDA UDI
Description
The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR Implant System can be used in dental implant applications, for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549107481 FDA UDI
510(k) Number
K151928 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Screw endosteal dental implant, two-piece

PUR NP Implant 5.0 x 10mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

Cleared under the same submission

K151928 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sterngold Dental LLC

Sources (1)

  • FDA UDI 0ef7591c-5897-48b8-8b81-3e32cd76a9b3 35 fields · synced Jun 8, 2026