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PURcrystals™ BioCeramic NanoCrystals

FDA UDI

Class II (US FDA UDI)

by Berkeley Advanced Biomaterials

Identity

Trade Name
PURcrystals™ BioCeramic NanoCrystals FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
PURcrystals™ BioCeramic Nanocrystals are a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. These materials have been the topic of extensive clinical studies for a several decades. PURcrystals™ is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. PURcrystals™ is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. FDA UDI
Model / Reference
PURcrystals-20 FDA UDI
Description
PURcrystals™ BioCeramic Nanocrystals are a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. These materials have been the topic of extensive clinical studies for a several decades. PURcrystals™ is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. PURcrystals™ is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. FDA UDI

Identifiers

Catalog Number
PURcrystals-20 FDA UDI
Primary DI / UDI-DI
00816125023950 FDA UDI
510(k) Number
K023703 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

PURcrystals™ BioCeramic NanoCrystals by Berkeley Advanced Biomaterials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K023703 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Berkeley Advanced Biomaterials

Sources (1)

  • FDA UDI 4f12c2c6-6e83-4794-a222-5c7524c314dd 35 fields · synced Jun 1, 2026