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Fiber-bond 1x5ml

FDA UDIEUDAMED

Class II (US FDA UDI)

by Polydentia SA

Identity

Trade Name
Fiber-bond 1x5ml FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Model / Reference
6525 FDA UDI

Identifiers

Primary DI / UDI-DI
E29965250 FDA UDI
510(k) Number
K962374 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Dentine bonding agent/set

Fiber-bond 1x5ml by Polydentia SA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K962374 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polydentia SA

Sources (2)

  • FDA UDI 4df3d7a5-5565-49b4-9499-dc27d986ffdd 33 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026