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CERALOG® PL Bonding base bridge, Ø 5.0 mm, GH 0.8 mm

FDA UDI

Class II (US FDA UDI)

by CeramTec Schweiz GmbH

Identity

Trade Name
CERALOG® PL Bonding base bridge, Ø 5.0 mm, GH 0.8 mm FDA UDI
Generic Name
Dental implant suprastructure kit FDA UDI
Device Name
CERALOG® PL Bonding base bridge, Ø 5.0 mm, GH 0.8 mm FDA UDI
Model / Reference
HP2247.5008 FDA UDI
Description
CERALOG® PL Bonding base bridge, Ø 5.0 mm, GH 0.8 mm FDA UDI

Identifiers

Catalog Number
HP2247.5008 FDA UDI
Primary DI / UDI-DI
07640161396654 FDA UDI
510(k) Number
K163043 FDA UDI
K180184 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure kit 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

No

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

CERALOG® PL Bonding base bridge, Ø 5.0 mm, GH 0.8 mm by CeramTec Schweiz GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163043 also covers:

K180184 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CeramTec Schweiz GmbH

Sources (1)

  • FDA UDI 1023cb83-d61d-4f89-a7ee-01ed051b9df7 37 fields · synced Jun 8, 2026