21 CFR 872.3660
Impression material
21 CFR 872.3660 is the regulation titled “Impression material” in 21 CFR Part 872, Dental Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 872.3660 (eCFR, as of Sep 1, 2026)
(a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.
(b) Classification. Class II (Special Controls).
[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 872.3660.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 801.3Definitions1 letter cites both
- 21 CFR 801.40Form of a unique device identifier1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 807.22Times for establishment registration and device listing1 letter cites both
- 21 CFR 807.65Exemptions for device establishments1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
Latest letters citing it
The letter citing 21 CFR 872.3660 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.