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Overdenture Abutment

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name
Overdenture Abutment FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Model / Reference
1037-62 FDA UDI

Identifiers

Catalog Number
1037-62 FDA UDI
Primary DI / UDI-DI
10841307114864 FDA UDI
510(k) Number
K061319 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

Yes

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

Overdenture Abutment by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K061319 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 ab7f5128-b668-46d5-9a1a-8e20b65f3d41 37 fields · synced Jun 8, 2026