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RP Low Margin Abutment Healing Cap

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name
RP Low Margin Abutment Healing Cap FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
The RP Low Margin Abutment, these abutments allow for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system; yet the same restorative procedures and instrumentation are used. The Low Margin Abutment is attached directly to the implant and allows for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system. Available in 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm cuff sizes. They accommodate up to 25% of total divergence between implants. Small diameter allows use at mandibular anterior sites. FDA UDI
Model / Reference
904350 FDA UDI
Description
The RP Low Margin Abutment, these abutments allow for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system; yet the same restorative procedures and instrumentation are used. The Low Margin Abutment is attached directly to the implant and allows for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system. Available in 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm cuff sizes. They accommodate up to 25% of total divergence between implants. Small diameter allows use at mandibular anterior sites. FDA UDI

Identifiers

Primary DI / UDI-DI
00841549111136 FDA UDI
510(k) Number
K946198 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

RP Low Margin Abutment Healing Cap by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 be1a9e48-d8db-4458-b85d-765162d4f940 36 fields · synced May 30, 2026