510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NMEClass I

Bur, Diamond Coated, Reprocessed

21 CFR 872.3240 / Dental
FDA source (opens on fda.gov)

NME is the FDA product code for Bur, Diamond Coated, Reprocessed, a class I device type, regulated under 21 CFR 872.3240. FDA's definition for this code reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
NME
Device name
Bur, Diamond Coated, Reprocessed
FDA definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 872.3240
Device class
Class I
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NME.