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Enamel Pro

by Premier Dental Products Co.

510(k) K062166

Enamel Pro is a medical device (FDA Class I; FDA product code EJR, Agent, Polishing, Abrasive, Oral Cavity) made by Premier Dental Products Co., cleared under FDA 510(k) K062166 on 21 Nov 2006, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062166 Date21 Nov 2006ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EJR
Device class
Class I
Regulation
21 CFR Part 872.6030
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K062166

28 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K062166
UDI-DISize and differences
Enamel Pro® Prophy Paste 9007600
PREMIER DENTAL PRODUCTS COMPANY
900760000348783005158
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007601
PREMIER DENTAL PRODUCTS COMPANY
900760100348783005165
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007602
PREMIER DENTAL PRODUCTS COMPANY
900760200348783005172
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007603
PREMIER DENTAL PRODUCTS COMPANY
900760300348783005189
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007604
PREMIER DENTAL PRODUCTS COMPANY
900760400348783005356
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007605
PREMIER DENTAL PRODUCTS COMPANY
900760500348783005363
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007606
PREMIER DENTAL PRODUCTS COMPANY
900760600348783005370
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007607
PREMIER DENTAL PRODUCTS COMPANY
900760700348783005325
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007608
PREMIER DENTAL PRODUCTS COMPANY
900760800348783005332
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007609
PREMIER DENTAL PRODUCTS COMPANY
900760900348783005349
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007610
PREMIER DENTAL PRODUCTS COMPANY
900761000348783005295
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007611
PREMIER DENTAL PRODUCTS COMPANY
900761100348783005301
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007612
PREMIER DENTAL PRODUCTS COMPANY
900761200348783005318
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007613
PREMIER DENTAL PRODUCTS COMPANY
900761300348783005196
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007614
PREMIER DENTAL PRODUCTS COMPANY
900761400348783005264
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007615
PREMIER DENTAL PRODUCTS COMPANY
900761500348783005271
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007616
PREMIER DENTAL PRODUCTS COMPANY
900761600348783005288
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007617
PREMIER DENTAL PRODUCTS COMPANY
900761700348783005202
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007618
PREMIER DENTAL PRODUCTS COMPANY
900761800348783005219
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007619
PREMIER DENTAL PRODUCTS COMPANY
900761900348783005226
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007620
PREMIER DENTAL PRODUCTS COMPANY
900762000348783005233
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007621
PREMIER DENTAL PRODUCTS COMPANY
900762100348783005240
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007622
PREMIER DENTAL PRODUCTS COMPANY
900762200348783005257
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007627
PREMIER DENTAL PRODUCTS COMPANY
900762700348783005394
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007630
PREMIER DENTAL PRODUCTS COMPANY
900763000348783005387
Prescription: yes; Single use: no
On the market
Enamel Pro® Prophy Paste 9007631
PREMIER DENTAL PRODUCTS COMPANY
900763100348783005400
Prescription: yes; Single use: no
On the market
PractiPro Mint TCP Prophy Paste Coarse 7159810 coa
PRACTICON, INC.
7159810 coa / 7159810 coa00723896021262
Prescription: no; Single use: yes
On the market
PractiPro Mint TCP Prophy Paste Medium 7159810 MED
PRACTICON, INC.
7159810 MED00723896008591
Prescription: no; Single use: yes
On the market

Similar devices

Other devices filed under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity).

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