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Straight Abutment Comfort Cap (2 pieces)

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name
Straight Abutment Comfort Cap (2 pieces) FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Model / Reference
3065-26 FDA UDI

Identifiers

Catalog Number
3065-26 FDA UDI
Primary DI / UDI-DI
10841307115090 FDA UDI
510(k) Number
K081396 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Straight Abutment Comfort Cap (2 pieces) by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K081396 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implant Direct Sybron Manufacturing Llc

Sources (1)

  • FDA UDI 61331cc4-4090-49ac-b756-c85300bf9e5d 37 fields · synced May 31, 2026