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Multi-Unit Comfort Cap

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name
Multi-Unit Comfort Cap FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Model / Reference
4000-13 FDA UDI

Identifiers

Catalog Number
4000-13 FDA UDI
Primary DI / UDI-DI
10841307126959 FDA UDI
510(k) Number
K060063 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
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

Category: Dental implant suprastructure, temporary, preformed, single-use

Multi-Unit Comfort Cap by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Cleared under the same submission

K060063 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 5213825a-750a-4c39-85ff-75c347e81a93 36 fields · synced May 31, 2026